Full Year Results 2018 - February 6, 2019 - Camurus
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Full Year Results
2018
February 6, 2019
Important information
The information in this presentation does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares,
subscription rights or other securities in Camurus in any jurisdiction. The information in this presentation may not be announced,
published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into the United States, Canada, Japan,
Australia, New Zealand, South Africa, Hong Kong, Singapore or in any other jurisdiction where such announcement, publication or
distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal
restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in
violation of this instruction may constitute a crime against applicable securities laws and regulations.
This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product
developments and regulatory approvals and financial performance.
Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and
inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-
looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate
fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent,
breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘
ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and
governmental laws and interpretation thereof, and unexpected cost increases.
Camurus undertakes no obligation to update forward-looking statements
2
Agenda
• Update on 2018 performance Participants
• Rights issue Fredrik Tiberg
President & CEO
• Buvidal® approvals and EU launch
Richard Jameson
• Brixadi™ US status
Chief Commercial Officer
• Pipeline progress
Eva Pinotti Lindqvist
• Q&A Chief Financial Officer
3
Company highlights
• In-house developed with strong IP
Unique FluidCrystal®
• New generation long-acting depot technology
nano-technology • Validated in 20 clinical trials and by approved products
Broad, late-stage • 10 clinical programs, in addiction, pain, oncology,
R&D pipeline endocrinology, obesity and CV
Approved • Buvidal® approved in EU and Australia for treatment Listed on Nasdaq STO (ticker CAMX)
commercial products of opioid dependence Market Cap: SEK ~2.7 billion
Employees: 100 (Jan. 31)
Own commercial • Fully operational for 2019 Buvidal® launches HQ: Lund, Sweden
organization in Europe and Australia
Regional offices: Cambridge, Mannheim,
Paris, Sydney
• Braeburn Pharmaceuticals, Rhythm, Solasia
Strong partnerships Pharma…
Experienced management and dedicated teams
4
Broad and diversified product pipeline
PRODUCT PRECLINICAL PHASE 1-2 PHASE 3 REGISTRATION MARKET
Buvidal® (CAM2038) q1w OPIOID DEPENDENCE APPROVED
Buvidal® (CAM2038) q4w OPIOID DEPENDENCE APPROVED
Brixadi® (CAM2038) q1w OPIOID DEPENDENCE 1 TENTATIVELY APPROVED
Brixadi® (CAM2038) q4w OPIOID DEPENDENCE 1 TENTATIVELY APPROVED
CAM2038 q1w CHRONIC PAIN1 PHASE 3
CAM2038 q4w CHRONIC PAIN1 PHASE 3
CAM2029 ACROMEGALY PHASE 1-2
CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2
CAM2032 PROSTATE CANCER PHASE 1-2
CAM4072 GENETIC OBESITY DISORDERS 3 PHASE 1-2
CAM2043 PULMONARY ARTERIAL HYPERTENSION PHASE 1-2
CAM2047 CHEMOTHERAPY INDUCED NAUSEA & VOMITING PHASE 1-2
CAM2048/58 POSTOPERATIVE PAIN & PONV 1,2 PHASE 1-2
1. Braeburn holds the rights to North America; 2. Postoperative nausea and vomiting; 3. Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal®
5
2018 operating performance and pipeline progress
Operating highlights Pipeline progress Full year financials 2018
Commercialization infra- Buvidal approved in both the
structure established in EU EU and Australia MSEK Full Year Q4
and Australia Net revenue
Tentative approval of Brixadi 49.3 (54.3) 7.8 (5.5)
Commercial manufacturing in the US Op. result -287.2 (-243.5) -103.2 (-66.1)
of Buvidal
Positive Phase 3 results for Result f. period -234.7 (-190.2) -87.1 (-55.2)
EU and Australia distribution CAM2038 in chronic pain Cash 134.4 (314.5)
network – 1st wave markets
Publ. of Buvidal Ph. 3 results
Launch platform established in JAMA Int. Med. Announcement of a fully underwritten
rights issue of SEK ~400 million,
------------------------------------------ Positive Ph. 1 SAD and MAD subject to approval by the Extra
results of CAM2043 General Meeting
Buvidal European launch
H1 2019
initiated in FI, SE, and the UK Publ. CAM2029 Ph. 2 results 6 February 2019
with positive initial feedback
Phase 1b clinical milestone in
• Next DE, DK, NO and AUS Rhythm collaboration
6
Fully underwritten Rights Issue of MSEK 400
Summary Background and reason
• New share issue of approximately • Unexpected delay of USD 35 million
SEK 400 million, with preferential rights for milestone payment due to tentative
the company’s shareholders approval of Brixadi in the US
• The Rights Issue is fully underwritten by • Use of proceeds:
current shareholders and external ‒ Launch and marketing of Buvidal in Europe
guarantors and Australia
• Shareholders with 69% of Company shares ‒ Phase 3 program for CAM2029 octreotide
have committed to vote in favor of the SC depot in acromegaly and NET
Rights Issue at the Extra General Meeting, ‒ Progress other prioritized R&D programs,
EGM, on 5 March 2019 such as CAM2043 treprostinil SC depot for
treatment of pulmonary arterial hypertension
• Final terms of the Rights Issue, including
subscription price, will be announced
28 February, ahead of the EGM
7
Buvidal®/Brixadi™ (CAM2038) Weekly and monthly buprenorphine depots Game-changer in opioid dependence treatment
Buvidal brings unique and significant values to patients, HCPs
and society
• Flexible dosing to match patient needs
CHOICE OF
WEEKLY MONTHLY MULTIPLE
Enhanced continuum of care with direct DOSING DOSING DOSES
INJECTION
SITES
initiation and switching from daily
treatments (‘‘dose matching”)
• Removes burden and stigma of daily
medication and increases adherence
SMALL LOW ROOM TEMP. CLINICAL DATA VS.
• HCP administration safeguards against NEEDLE VOLUMES STORAGE ACTIVE CONTROL
diversion, misuse and pediatric exposure
• Potential game-changer in opioid
dependence treatment 23 gauge 0.16 – 0.64 mL
Source: 1. CAM2038 is an investigational medicinal product and is currently not approved in any market
9
Strong clinical data for Buvidal® Recent publications versus daily standard treatment Non-inferior and Superior efficacy demonstrated in pivotal Phase 3 study versus standard daily SL BPN/NX1 Effective suppression of withdrawal and cravings1,2,3 Blockade of opioid effects from the first dose2 Safety profile comparable to SL BPN/NX except for mild and moderate injection site reactions1 No opioid overdoses across clinical studies for participants treated with Buvidal®1,2,3,5 High patient satisfaction including versus SL BPN6 1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 3Haasen, C, et al, J Subst Abuse Treat. 2017;78:22-29; 4Albayaty M, et al, Adv Ther. 2017 34(2):560-575; 5Lintzeris et al., Drug and alcohol 10 review. 2017;36(S1):47-48, 6Study HS-14-499, data on file. SL BPN sublingual buprenorphine/naloxone
High satisfaction amongst patients
“CAM2038 compared to my previously prescribed
sublingual buprenorphine treatment”
Much better
H
Slightly better
About the same N=133 83% POSITIVE
Slightly worse
Much worse
11
Source: Poster presentation ASAM 2018. Phase 3 Long-Term Safety Study HS-14-499, data on file.Limited competition on long-acting injectable (LAI)
opioid dependence market
Long-acting buprenorphine injectables
PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL
US Tentative approval Dec 2018
Camurus/
Buvidal Weekly & Monthly Europe Approved Nov 2018
Braeburn
Australia Approved Nov 2018
US Approved Nov 2017
Indivior Sublocade™ Monthly Europe No information
Australia Estimated Q3 2019
Long-acting naltrexone injectable
Alkermes Vivitrol® 2017 sales $269M2 US Approved 2010
Source: 1. Indivior, Q2 Financial Results, May 2, 2018; 2. GlobalData 2018. 12Buvidal® – first long-acting injection treatment
of opioid dependence in the EU and Australia
• Indication statement in EU: For treatment of opioid dependence within a framework of
medical, social and psychological treatment in adults and adolescents from 16 years
• All treatment phases: Treatment initiation, switching from daily medications, and long-term
maintenance treatment
• Superiority versus daily standard treatment with sublingual buprenorphine/
naloxone for CDF % urine tests negative for illicit opioids included in clinical outcomes
Source: Buvidal Summary of Product Characteristics (SmPC), 2018 13
INTERNAL USE ONLY. NOT TO BE CONSIDERED BRIEFING MATERIAL FOR REPRESENTATIVES.European Buvidal® launch initiated
Wave 1 markets
HQ ‒ Launched in Finland, Sweden,
Lund
and the UK
Sweden
• Positive anecdotal feedback
Cambridge • Germany, Denmark, Norway, Australia Q1/Q2
UK
Launch sequence ‒ Teams recruited and onboarded
Wave 1 markets • 55 heads, 83% customer facing
Wave 2 markets • Supply and distribution models in place
Paris Wave 3 market growth
France
Wave 4 expansion Wave 2 markets
‒ Market access and medical education
• Pricing & reimbursement
Mannheim
‒ Key functions onboarded (10 heads)
Germany
• Spain, Italy, France, target launch Q4 ‘19/Q1 ‘20
Sydney
Australia • Israel – Medison Q1 ‘20
14~740,000 patients estimated as suitable for
buprenorphine LAI treatments in EU and Australia
Patients on Bup1 Patients on low dose Patients recycling Users out of treatment Total addressable
Methadone ≤30mg2 within a year1 due to rules & burden1,3,4 market
1. EMCDDA 2018 Drug report 2. Camurus estimate 3. Benyamina et al 2013 Heroin Addiction and Related Clinical Problems 14 (4): 65-80. 4. Camurus data on file 2018 Patient qualitative study . 15Base-case market estimate for buprenorphine LAIs for
opioid dependence treatments in EU and Australia
740,0001 20 – 30% Average Pricing Estimated
addressable on long-acting length of comparable market size
patients in EU injectables in treatment with depot €200 - €300m
and Australia base case2,3 ~180 days antipsychotics for LAIs at peak
1.See previous slide; 2.Market access dynamics in opioid addiction, Decision Resources 2015; 3. Camurus data Simon Kuchner and Partners pricing research 2018 16Making Brixadi™ available to
US patients
• Tentative approval received 21 December 2018 7 days or less buprenorphine
prescriptions most common in the US
• Final approval of Brixadi™ Monthly currently
subject to expiration of an exclusivity period
until Nov. 2020, unless earlier resolved
28 days+ 7 day Rx
• Braeburn is pursuing several options to make Rx most
Brixadi™ available to US patients as soon as common
possible 34% 40%
• Brixadi™ Weekly is not blocked by exclusivity
and can be approved separately
26%
8–27 day Rx
Source: Symphony Health Solutions, Patient Tracker, 2017 17Significant market potential estimated
for Brixadi™ in the US GlobalData estimates of opioid
dependence market in the US1
• Escalating opioid crisis Long-acting injectables
US$ 4.3 billion
• High unmet need and disease awareness Daily medication
• Significant interest from patients, US$ 1.8 billion
$1.2 billion
prescribers and payers $264 m
• Opioid dependence market predicted $3.1 billion
to grow by 10% CAGR
$1.3 billion
• US Bixadi™ sales in 2027 estimated to 2017 2027
US$ 1.2 billion in by GlobalData1
• “Long-acting injectables are likely to become
the new gold standard of treatment”
• >100,000 US patients estimated to be treated
with Brixadi™ (CAM2038) in 20271
Source: 1. Opioid Use Disorder (OUD): Opportunity Analysis and Forecasts to 2027, GlobalData 2018 18Registration program for CAM2038 in chronic
pain targets opioid experienced patients
Positive Ph. 3 results and ongoing
long-term safety extension study
1 IN 5 INDIVIDUALS SUFFER
FROM CHRONIC PAIN1
Scientific advice/pre-MAA meetings
with health authorities
CHRONIC PAIN ESTIMATED
~US$560-
MAA submissions to EMA and TGA
expected first half of 2020
Focus on high risk, high need 635bn
opioid experienced patients ANNUAL COST TO SOCIETY2
19Long-acting octreotides for neuroendocrine tumors (NET) and acromegaly CAM2029 update
Next generation long-acting
somatostatin analogs (SSAs)
SOMATOSTATIN ANALOGUE SALES2
mUSD
• Octreotide SC depot (CAM2029) for acromegaly 2500
Somatuline® (Ipsen)
and neuroendrocrine tumors (NET) Sandostatin® LAR® (Novartis)
2250
2000
‒ FluidCrystal® formulated for ease of administration 1750
1500
‒ Enhanced (~500%) octreotide exposure for improved 1250
efficacy1 1000
750
‒ Publication of positive Phase 2 data2 500
250
‒ Phase 3 program to start by mid-2019 (international 0
advisory team in place)
• Additional FluidCrystal® based SSA products - 20 years of strong market growth, 12% CAGR
under development for rare diseases - Small concentrated prescriber base
- Long-acting SSA US price-range: $51,000 to
‒ Preclinical data suggest effective inhibition of tumor $146,000 WAC / year3
growth and hormonal secretion and good tolerability
Source: 1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2. GlobalData 2017; 2US weighted average cost for mid-range doses, 2018 21
2. Pavel M et al, Cancer Chemotherapy and Pharmacology, 2018, available onlinePlans for continued development of CAM2029
ACRO Phase 3 PC
ACRO Phase 3 LTSE
Phase 2, MAD
Placebo controlled (PC) Phase 3
Phase 1, MAD study in SSA responders (N~80).
Open label, long-term safety
extension in full/partial responders
Phase 1, MAD
Phase 1, SAD
Four clinical trials completed in
healthy subjects and patients NET Phase 3 AC + LTSE
characterizing PK, PD and Active controlled (AC) Phase 3
safety profile (N=249) study in patients with metastatic,
well or moderately differentiated
NET.
H2 2019 2021
22Selection of anticipated milestone events to 2021
2019 2020 2021
Commercial
Buvidal® 1st wave launches Buvidal® 2nd wave Buvidal 3rd wave Buvidal geographic CAM2038 launch in
in EU and Australia launches in EU launches in EU and expansion chronic pain
Israel
Potential early US launch of Brixadi1 Expiry of Sublocade™
US exclusivity
H1 H2 H1 H2
CAM2029 Ph 3 ACRO start DEBUT study results CAM2038 MAA for CAM2029 Ph 3 ACRO MAA approval for
Buvidal® DEBUT study fully CAM2029 Ph 3 NET chronic pain submitted fully enrolled CAM2038 in EU/AUS
R&D
enrolled study start UNLOC-T study results CAM2043 Ph 3 start Phase 3 CAM2029
CAM2038 Ph 3 long-term CAM2043 Ph 2 start CAM2043 Ph 2 results ACRO results
safety results
H1 H2 H1 H2
Corporate
Completed Rights Issue Out-licensing of clinical product candidate Sustained profitability
New FluidCrystal® technology partnerships Positive cash-flow expected from H2 2020 Three commercial stage
Revenue prognosis provided in Q2 2019 Leadership in opioid dependence treatment in EU assets
1Weekly Brixadi only until expiry of Sublocade product exclusivity November 2020 or other early resolution
23Camurus positioned for significant value creation
• Leading FluidCrystal® technology platform used in house and
in multiple partnerships with biotech and pharma partners
• Broad and de-risked clinical pipeline targeting multi-billion dollar
specialty markets
• Multiple levers for value creation through product development, approvals,
partnerships and own commercialization
• Buvidal® launched as first long-acting medicine in the EU followed by Australia
• Significant near-term revenue potential from sales, milestones and royalty
2425
The first weekly and monthly individualized treatment for opioid
dependence
Buvidal® weekly Buvidal® monthly
is available in 8 mg, 16 mg, 24 mg, 32 mg preparations is available in 64 mg, 96 mg, 128 mg preparations
Camurus. Buvidal® Summary of Product Characteristics (SmPC). Camurus AB, Sweden. November 2018.Q&A
26Thank You Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden info@camurus.com camurus.com
Key Shareholders (31 December 2018)
Financial overview Others
30,1% Sandberg
Development
53,2%
Backahill Utveckling
2,29%
MSEK Q4 2018 Q4 2017 FY 2018 FY 2017 Fjärde AP-fonden
2,33%
Net Sales 7.8 5.5 49.3 54.3
Catella Fondforvaltning
2,49%
Operating result -103.2 -66.1 -287.2 -243.5
Fredrik Tiberg Gladiator
3,94% 6,49%
Result after tax -87.1 -55.2 -234.7 -190.6
Earnings per share Listed on Nasdaq STO (ticker CAMX)
SEK before and -2.27 -1.40 -6.20 -5.11 Market Cap: SEK ~3 billion (USD ~320 million)
after dilution
Cash position: USD ~15 million (31 Dec 2018)
Cash position 134.4 314.5 134.4 314.5 Employees: 100
HQ: Lund, Sweden
Regional offices: Cambridge, Mannheim,
Paris, Sydney
28P&L in Summary
Q4 2018 and Full Year 2018
2018 2017 2018 2017
KSEK Oct-Dec Oct-Dec Jan-Dec Jan-Dec Comments on Full Year 2018:
Net revenues 7,805 5,458 49,321 54,308
• Revenues include: milestone payments
Cost of goods sold -3,937 -754 -6,822 -1,356
from Braeburn for positive CAM2038 Phase
3 pain results and from Rhythm for
Gross profit 3,868 4,704 42,499 52,952
completion of Phase 1b study of CAM4072,
and episil® sales and royalty
Marketing and distribution costs -39,547 -11,347 -100,884 -45,893
Administrative expenses -6,212 -11,055 -21,999 -26,590 OPEX
Research and development costs -61,863 -48,142 -207,664 -222,939
Other operating income 565 34 830 93 • Establishment of commercialization
Other operating expenses - -269 - -1,147 infrastructure, including market access,
Operating result -103,189 -66,075 -287,218 -243,524 medical affairs, marketing and sales teams.
• Commercial manufacturing and distribution
Finance income 59 51 175 174
of Buvidal, including preparations
Finance expenses -3 -3 -25 -18
Net financial items 56 48 150 156 • Therapeutic use (Phase 4) clinical study of
Buvidal in Australia and Phase 1 clinical
Result before tax -103,133 -66,026 -287,068 -243,368 study of CAM2043
Income tax 15,986 13,836 52,392 52,794
Result for the period -87,147 -52,190 -234,676 -190,574Upcoming Events 2019
Date Event
6 February 2019 Full Year Report 2018 (conference call)
5 March 2019 Carnegie Nordic Healthcare Seminar, Stockholm, Sweden
5 March 2019 Extraordinary General Meeting
11-13 March 2019 Cowen & Co Healthcare Conference, Boston, MA
25-27 March 2019 BIO-Europe Spring, Vienna, Austria
5 April 2019 Annual Report 2018
9 May 2019 Interim Report January-March 2019
9 May 2019 Annual General Meeting, Lund, Sweden
4-7 June 2019 Jefferies Healthcare Conference, New York, NY
5-8 June 2019 BIO convention, Philadelphia, PA
17 July 2019 Interim Report January-June 2019
8 November 2019 Interim Report January-September 2019
30EU ABBREVIATED PRESCRIBING INFORMATION
Buvidal® (buprenorphine) prolonged-release solution for injection
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Presentations: Prolonged-release solution for injection in pre-filled syringes containing buprenorphine for weekly injection (8 mg, 16 mg, 24 mg, 32 mg) or monthly injection (64 mg, 96 mg, 128 mg).
Indication: Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
Dosage and Administration: Administration of Buvidal® is restricted to healthcare professionals. Appropriate precautions, such as to conduct patient follow-up visits with clinical monitoring to the patient´s needs,
should be taken when prescribing and dispensing buprenorphine. Take-home use or self-administration of the product by patients is not allowed. Precautions to be taken before initiation of treatment: To avoid
precipitating symptoms of withdrawal, treatment with Buvidal® should be started when objective and clear signs of mild to moderate withdrawal are evident. For patients using heroin or short-acting opioids, the initial
dose of Buvidal® must not be administered until at least 6 hours after the patient last used opioids. For patients receiving methadone, the methadone dose should be reduced to a maximum of 30 mg/day before
starting treatment with Buvidal® which should not be administered until at least 24 hours after the patient last received a methadone dose. Buvidal® may trigger withdrawal symptoms in methadone-dependent
patients. Initiation of treatment in patients not already receiving buprenorphine: Patients not previously exposed to buprenorphine should receive a sublingual buprenorphine 4 mg dose and be observed for an hour
before the first administration of weekly Buvidal® to confirm tolerability to buprenorphine. The recommended starting dose of Buvidal® is 16 mg, with one or two additional 8 mg doses at least 1 day apart, to a target
dose of 24 mg or 32 mg during the first treatment week. The recommended dose for the second treatment week is the total dose administered during the week of initiation. Treatment with monthly Buvidal® can be
started after treatment initiation with weekly Buvidal®, in accordance with the dose conversion in Table 2 of the full SmPC and once patients have been stabilised on weekly treatment (four weeks or more, where
practical). Switching from sublingual buprenorphine products to Buvidal®: Patients treated with sublingual buprenorphine may be switched directly to weekly or monthly Buvidal®, starting on the day after the last daily
buprenorphine sublingual treatment dose in accordance with the dosing recommendations in the full SmPC. Maintenance treatment and dose adjustments: Buvidal® can be administered weekly or monthly. Doses
may be increased or decreased and patients can be switched between weekly and monthly products according to individual patient’s needs and treating physician’s clinical judgement as per recommendations in the
full SmPC. Following switching, patients may need closer monitoring. Assessment of long-term treatment is based on 48-week data. Supplemental dosing: A maximum of one supplemental Buvidal® 8 mg dose may
be administered at an unscheduled visit between regular weekly and monthly doses, based on individual patient’s temporary needs. The maximum dose per week for patients who are on weekly Buvidal® treatment
is 32 mg with an additional 8 mg dose. The maximum dose per month for patients who are on monthly Buvidal® treatment is 128 mg with an additional 8 mg dose. Missed doses: To avoid missed doses, the weekly
dose may be administered up to 2 days before or after the weekly time point, and the monthly dose may be administered up to 1 week before or after the monthly time point. If a dose is missed, the next dose should
be administered as soon as practically possible. Termination of treatment: If Buvidal® treatment is discontinued, its prolonged-release characteristics and any withdrawal symptoms experienced by the patient must
be considered. If the patient is switched to treatment with sublingual buprenorphine, this should be done one week after the last weekly dose or one month after the last monthly dose of Buvidal® according to the
recommendations in the full SmPC.
Method of administration: Buvidal® is intended for subcutaneous administration only. It should be injected slowly and completely into the subcutaneous tissue of different areas (buttock, thigh, abdomen, or upper
arm), provided there is enough subcutaneous tissue. Each area can have multiple injection sites. A minimum of 8 weeks should be left before re-injecting a previously used injection site with the weekly dose.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Severe respiratory insufficiency. Severe hepatic impairment. Acute alcoholism or delirium tremens.
31Special warnings and precautions for use: Care must be taken to avoid inadvertent injection of Buvidal®. The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally.
Intravascular such as intravenous injection would present a risk of serious harm as Buvidal forms a solid mass upon contact with body fluids, which potentially could cause blood vessel injury, occlusion, or
thromboembolic events. To minimise the risk of misuse, abuse or diversion, appropriate precautions should be taken when prescribing and dispensing buprenorphine. Healthcare professionals should administer
Buvidal directly to the patient. Take-home use or self-administration of the product by patients is not allowed. Any attempts to remove the depot should be monitored throughout treatment. The prolonged-release
properties of the product should be considered during treatment including initiation and termination. In particular, patients with concomitant medicinal products and/or co-morbidities, should be monitored for signs
and symptoms of toxicity, overdose or withdrawal caused by increased or decreased levels of buprenorphine. Buprenorphine should be used with care in patients with respiratory insufficiency. Buprenorphine may
cause drowsiness particularly when taken together with alcohol or central nervous system depressants such as benzodiazepines, tranquilisers, sedatives, gabapentinoids or hypnotics. Buprenorphine is a partial
agonist at the mu-opiate receptor and chronic administration can produce opioid dependence. Baseline liver function tests and documentation of viral hepatitis status are recommended prior to starting therapy.
Buprenorphine products have caused precipitated withdrawal symptoms in opioid-dependent patients when administered before the agonist effects resulting from recent opioid use or misuse have subsided.
Buprenorphine should be used with caution in patients with moderate hepatic impairment. Hepatic function should be monitored regularly whilst on treatment. The use of buprenorphine is contraindicated in
patients with severe hepatic impairment. Caution is recommended when dosing patients with severe renal impairment. Caution should be exercised when co-administering Buvidal® with other medicinal products
that prolong the QT interval and in patients with a history of long QT syndrome or other risk factors for QT prolongation. For management of acute pain during continued use of Buvidal®, a combination of use of
opioids with high mu-opioid receptor affinity (e.g. fentanyl), non-opioid analgesics and regional anaesthesia might be necessary. Titration of oral or intravenous short-acting opioid pain medicinal products
(immediate-release morphine, oxycodone or fentanyl) to the desired analgesic effect in patients treated with Buvidal® might require higher doses. Patients should be monitored during treatment. Interactions: No
interaction studies have been performed with Buvidal®. See SmPC for precautions when co-administering buprenorphine with other drugs. Fertility, pregnancy and lactation: Buprenorphine should be used during
pregnancy only if the potential benefit outweighs the potential risk to the foetus. Towards the end of pregnancy, buprenorphine may induce respiratory depression in the newborn infant even after a short period of
administration. Buprenorphine and its metabolites are excreted in human breast milk and Buvidal® should be used with caution during breast-feeding. There are no or limited data on effects of buprenorphine on
human fertility. Driving and operating machines: Buprenorphine has minor to moderate influence on the ability to drive and use machines when administered to opioid-dependent patients. The patient should be
cautioned not to drive or operate hazardous machinery whilst taking this medicine until it is known how the patient is affected by the medicine.
Undesirable effects: The adverse reactions most frequently reported for buprenorphine are headache, nausea, hyperhidrosis, insomnia, drug withdrawal syndrome and pain. Very common (≥ 1/10): insomnia,
headache, nausea, hyperhidrosis, drug withdrawal syndrome, pain. Injection site reactions: in the double-blind, phase 3 efficacy trial, injection site-related adverse reactions were observed in 36 (16.9%) of the
213 patients (5% of the administered injections) in the Buvidal® treatment group. The most common adverse reactions were injection site pain (8.9%), injection site pruritus (6.1%) and injection site erythema
(4.7%). The injection site reactions were all mild or moderate in severity and most events were transient. See full SmPC for further details of adverse reactions.
Overdose: General supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient. Symptomatic treatment of respiratory depression, following standard
intensive care measures, should be instituted. The long duration of action of buprenorphine and the prolonged release from Buvidal®, should be taken into consideration when determining length of treatment
needed to reverse the effects of an overdose.
Package quantities: Pack contains 1 pre-filled syringe with stopper, needle, needle shield, safety device and 1 plunger rod. Pre-filled syringes for weekly injection: 8 mg, 16 mg, 24 mg, 32 mg. Pre-filled syringes
for monthly injection: 64 mg, 96 mg, 128 mg.
Marketing authorisation numbers: EU/1/18/1336/001, EU/1/18/1336/002, EU/1/18/1336/003, EU/1/18/1336/004, EU/1/18/1336/005, EU/1/18/1336/006, EU/1/18/1336/007.
Legal category: Prescription medicine. Further information is available from the Marketing Authorisation Holder: Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden. Phone: +800 2577 2577.
Date of preparation: December 2018. Internal approval number (from Veeva): INT-BUV-1800007.
Adverse events should be reported according to national guidelines.
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