Camurus announced today that the Australian Therapeutic Goods Administration (TGA) has approved the company’s lead products Buvidal® Weekly and Buvidal® Monthly (CAM2038) for maintenance treatment of opioid dependence within a framework of medical, social and psychosocial support.
Lund, Sweden — 28 November 2018 — Camurus announced today that the Australian Therapeutic Goods Administration (TGA) has approved the company’s lead products Buvidal® Weekly and Buvidal® Monthly (CAM2038) for maintenance treatment of opioid dependence within a framework of medical, social and psychosocial support.
“Opioid dependence and non-medical opioid use are large and growing issues in Australia with significant negative impact on individuals, their families and the wider community,” said Fredrik Tiberg, President and CEO of Camurus. “Today’s approval of Buvidal Weekly and Buvidal Monthly will for the first time give Australian patients access to a long-acting buprenorphine treatment for opioid dependence with a meaningful clinical benefit recognized by the TGA.
Formulated with Camurus’ proprietary FluidCrystal® injection depot technology, Buvidal is a lipid-based solution which, once injected, transforms into a nanostructured gel-like depot. The depot slowly biodegrades over time, releasing buprenorphine which blocks the drug-liking effect of opioids in the brain and reduces withdrawal, craving and patient’s use of illicit opioids. [1-4]
“The introduction of Buvidal represents the most significant development in over 15 years of opioid dependence treatment in Australia. The flexibility of weekly and monthly injection depots will make treatment much more convenient for patients, reducing the costs and inconvenience of daily dosing, and should serve to lessen the stigma experienced by many patients,” said Professor Nicholas Lintzeris, Director of Drug & Alcohol Services, South East Sydney Local Health District and the Division of Addiction Medicine, Central Clinical School, University of Sydney. 
The TGA approval of Buvidal Weekly and Buvidal Monthly is based on safety and efficacy data from a global development program comprising seven clinical studies, including a randomized, double-blind, double-dummy, active controlled Phase 3 study in 428 patients with opioid dependence. Results from this study demonstrated improved treatment outcomes with Buvidal compared to daily standard treatment with sublingual buprenorphine/naloxone. 
The Australian approval follows the recent European Commission approval of Buvidal®, announced 22 November 2018. In the US, the Food and Drug Administration has issued a PDUFA goal date of 26 December 2018 for CAM2038 to Camurus’ US partner Braeburn.
About opioid dependence
Opioid dependence is an escalating global health problem, contributing to significant mental, physical and social adverse consequences that include transmission of infectious diseases, criminal activity and incarceration, and unintentional overdose and death. 
Opioid use is a serious public health issue in Australia with an estimated 460,000 people aged over 14 years having used opioids – including morphine, oxycodone, methadone and heroin – for non-medical purposes at some time.  Of these, 230,000 had used heroin.  In 2016, 1,808 drug-induced deaths were registered in Australia, the highest number of drug deaths in 20 years.  On a sample day in 2017, approximately 50,000 people in Australia received pharmacotherapy treatment for opioid dependence. 
About Buvidal Weekly and Buvidal Monthly (CAM2038)
Buvidal Weekly and Buvidal Monthly (modified release solution for subcutaneous injection) has been developed for the treatment of opioid dependence within a framework of medical, social and psychological treatment. Buvidal is designed for flexible weekly and monthly dosing, allowing tailored treatment to the patient’s individual needs. Each injection should be administered by a health care professional.
The TGA approval of Buvidal Weekly and Buvidal Monthly is based on a clinical program with seven clinical studies, including a randomized, double-blind, double-dummy, active controlled Phase 3 study in 428 patients with opioid dependence. In this pivotal study, Buvidal was shown to be at least as effective as effective as standard treatment with daily buprenorphine/naloxone for the primary endpoint of the mean percent urines negative for illicit opioids (35.1% versus 28.4%, p< 0.001). Superiority was met for the key secondary endpoint of cumulative distribution function (CDF) for the percent urine tests negative for illicit opioid use (p=0.008). The median CDF was 26.7% for Buvidal and 6.7% for sublingual buprenorphine/naloxone. The safety profile of Buvidal was comparable to sublingual buprenorphine/naloxone, except for mild to moderate injection site reactions.
Formulated with Camurus’ FluidCrystal injection depot technology, Buvidal is presented ready for use in pre-filled syringes for administration as small dose volume subcutaneous injection through a thin, 23-gauge needle. Buvidal has been developed for room temperature storage.
Camurus is a Swedish research-based pharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal drug delivery technologies and its extensive R&D expertise. Camurus’ clinical pipeline includes products for the treatment of cancer, endocrine diseases, pain and addiction, which are developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com.
PBS information: Buvidal is not listed on the PBS.
Important safety information
RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS INJECTION: Serious harm or death could result if administered intravenously. Buvidal Weekly and Monthly forms a gel depot upon contact with body fluids and may cause occlusion, local tissue damage and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. CONTRAINDICATIONS: Hypersensitivity to buprenorphine or to any of the excipients, children less than 16 years of age, severe respiratory insufficiency, severe hepatic insufficiency (Child-Pugh C), acute alcoholism or delirium tremens, pregnancy, lactation. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: General: Opioids may cause orthostatic hypotension in ambulatory patients. Opioids should be used with caution in patients with: head injury, intracranial lesions, other circumstances where cerebrospinal pressure may be increased, or history of seizure, hypotension, prostatic hypertrophy or urethral stenosis, myxoedema, hypothyroidism, or adrenal cortical insufficiency (eg Addison’s disease), dysfunction of the biliary tract; the elderly or debilitated. Opioid-induced miosis, changes in the level of consciousness or changes in the perception of pain as a symptom of disease may interfere with patient evaluation or obscure the diagnosis or clinical course of concomitant disease. Misuse, abuse and diversion: Buprenorphine is subject to misuse, abuse and diversion, similar to other opioids, legal or illicit. Buvidal must be administered directly to the patient by a healthcare professional. Buvidal should not be made available directly to patients. Monitor patients carefully for progression of opioid dependence and drug use. Respiratory depression: Buprenorphine should be used with care in patients with respiratory insufficiency (eg chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis). The use of buprenorphine is contraindicated in patients with severe respiratory insufficiency. Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-dependent persons who accidentally or deliberately ingest it. CNS depression: Buprenorphine may cause drowsiness particularly when taken together with alcohol or central nervous system depressants such as benzodiazepines, tranquillisers, sedatives, gabapentinoids or hypnotics. Dependence: Buprenorphine is a partial agonist at the µ (mu)-opioid receptor and chronic administration can produce opioid dependence. Use in hepatic impairment: Buprenorphine should be used with caution in patients with moderate hepatic impairment. The use of buprenorphine is contraindicated in patients with severe hepatic insufficiency. Use in renal impairment: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min). INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS: Buprenorphine should be used cautiously when co-administered with: benzodiazepines, gabapentinoids, alcoholic or medications containing alcohol, other central nervous system depressants: other opioid derivatives; certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances, opioid analgesics, naltrexone and nalmefene, CYP3A4 inhibitors and inducers, monoamine oxidase inhibitors (MAOI). PREGNANCY AND LACTATION: Use in pregnancy – Pregnancy Category C: Buvidal is contraindicated in pregnant women Use in lactation: Buvidal should not be used in breast-feeding women. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Patients should be cautioned about operating hazardous machinery in case buprenorphine may affect their ability to engage in such activities. ADVERSE EFFECTS: The adverse events most frequently reported in the double-blind, pivotal phase 3 efficacy clinical trial were constipation, symptoms commonly associated with drug withdrawal, such as headache, nausea, insomnia and vomiting, injection site related events such as injection site pain, injection site pruritus and injection site erythema, urinary tract infection and upper respiratory tract infection. Adverse reactions reported with buprenorphine: The following adverse reactions have been reported with the use of buprenorphine products and may occur with Buvidal. Very common: Insomnia, headache, nausea, hyperhidrosis, drug withdrawal syndrome, and pain. Common: Bronchitis, infection, influenza, pharyngitis, rhinitis, lymphadenopathy, decreased appetite, agitation, anxiety, depression, hostility, nervousness, paranoia, thinking abnormal, dizziness, hypertonia, migraine, paraesthesia, somnolence, syncope, tremor, lacrimal disorder, mydriasis, palpitations, vasodilatation, cough, dysnpoea, yawning, abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, gastrointestinal disorder, flatulence, vomiting, rash, arthralgia, back pain, bone pain, muscle spasms, myalgia, neck pain, dysmenorrhoea, asthenia, chest pain, chills, malaise, oedema peripheral and pyrexia. OVERDOSE: Respiratory depression, as a result of central nervous system depression, is the primary symptom requiring intervention in the case of buprenorphine overdose because it may lead to respiratory arrest and death. Symptomatic treatment of respiratory depression, following standard intensive care measures, should be instituted. Use of an opioid antagonist (ie naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents. The long duration of action of buprenorphine and the modified release from Buvidal, should be taken into consideration when determining length of treatment needed to reverse the effects of an overdose. Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia) for advice.
Notes and references
1. Haasen C, Linden M, Tiberg F. Pharmacokinetics and pharmacodynamics of a buprenorphine subcutaneous depot formulation (CAM2038) for once-weekly dosing in patients with opioid use disorder. J Subst Abuse Treat 2017; 78:22–29.
2. Albayaty M, Linden M, Olsson H, Johnsson M, Strandgården K, Tiberg F. Pharmacokinetic evaluation of once-weekly and once-monthly buprenorphine subcutaneous injection depots (CAM2038) versus intravenous and sublingual buprenorphine in healthy volunteers under naltrexone blockade: an open-label Phase 1 study. Adv Ther 2017; 34(2):560–575.
3. Walsh SL, Comer SD, Lofwall MR, Vince B, Levy-Cooperman N, Kelsh D, et al. Effect of buprenorphine weekly depot (CAM2038) and hydromorphone blockade in individuals with opioid use disorder: a randomized clinical trial. JAMA Psychiatry 2017; 74(9):894–902.
4. Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, et al. Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: A randomized clinical trial. JAMA Intern Med 2018; 178(6)764–773.
5. Dr. Lintzeris is an investigator in the Buvidal clinical program which was sponsored by Braeburn and Camurus. In relation to this media announcement, no compensation was provided to Dr Lintzeris, and the opinions expressed are his own. Dr Lintzeris has been briefed by Camurus on the approved use of this product.
5. World Drug Report 2018, United Nations June 2018 https://www.unodc.org/wdr2018/ Accessed November 2018.
6. National opioid pharmacotherapy statistics (NOPSAD) 2016. https://www.aihw.gov.au/reports/alcohol-other-drug-treatment-services/national-opioid-pharmacotherapy-statistics-nopsad-2016/contents/introductionAccessed November 2018.
7. Australian Bureau of Statistics. Causes of death, Australia 2016. Drug Induced Deaths in Australia: A changing story. http://www.abs.gov.au/ausstats/abs@.nsf/Lookup/by%20Subject/3303.0~2016~Main%20Features~Drug%20Induced%20Deaths%20in%20Australia~6 Accessed November 2018.
8. National opioid pharmacotherapy statistics (NOPSAD) 2017. https://www.aihw.gov.au/reports/alcohol-other-drug-treatment-services/nopsad-2017/contents/summary Accessed November 2018.
For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
Fredrik Joabsson, VP Business Development
Tel. +46 (0)70 776 17 37
Ruari MacDonald, Business Unit Head Australia
Tel. +61 418 760 988
Starting June 2019, all Sandberg Development's office and production facilities will be cleaned and washed with DIRO® water - completely without chemicals.Read more
Camurus’ partner, Braeburn Inc., has initiated court proceedings foran approval of Brixadi (Buvidal® in the US) and to overturn the 3-year market exclusivity granted by the FDA to another product.Read more
New positive results from a Phase 3 study show that Camurus’ Buvidal® provides better treatment effect for fentanyl abuse, among other things, compared to other standard treatments as well as lower withdrawal and drug craving.Read more
Camurus’ rights issue of 403 MSEK has been oversubscribed. The rights issue was carried out to secure financing of the launch and marketing of Buvidal in Europe and Australia.Read more
Aimpoint has been awarded a large contract of USD 24 million from the U.S. Military for the FCS13-RE system for SAAB’s portable weapon system Carl-Gustaf (MAAWS) and to be used by the U.S. Army, U.S. Marine Corps and the U.S. Special Operations Command.Read more
Based on Aimpoint's red dot sight for fire arms, the company has developed a commercial VR platform, GAIM, which is now spun off to a separate company.Read more
In 1959, Gunnar Sandberg established ElektroSandberg and lay the foundation for what we now know as Sandberg Development.Read more
Camurus' has published their Full year report 2018.Read more
As of January 7 Mikael Samuelsson is the new CEO for GRANULDISK.Read more
During the summer it was decided to spin off operations focused on the decontamination of fire rescue equipment from GRANULDISK into a separate company - RESCUE Intellitech.Read more
In November 2019 Mats Marklund took office as CEO for SWATAB.Read more
Camurus announced today that the Australian Therapeutic Goods Administration (TGA) has approved the company’s lead products Buvidal® Weekly and Buvidal® Monthly (CAM2038) for maintenance treatment of opioid dependence within a framework of medical, social and psychosocial support.Read more
Camurus receives EU approval for weekly and monthly Buvidal® (CAM2038) for opioid dependence. Buvidal® is the first long-acting medicine approved in the EU for the treatment of opioid dependence in adults and adolescents.Read more
“Following the positive CHMP opinion for Buvidal®, we have ramped up our commercial activities and are ready for launch in the first wave European markets”, Fredrik Tiberg, President and CEO, says in his CEO comments.Read more
AF Bostäder in Lund will open two new laundry rooms at Vildanden, a student housing, where the students can wash with super-clean water in a chemical-free process.Read more
Sandberg Development has decided to spin-off and concentrate the business within the subsidiary GRANULDISK’s product area SOLO Rescue.Read more
The family owned investment company Sandberg Development invests in SWATAB (SCANDINAVIAN WATER TECHNOLOGY AB). The investment implies a growth venture with an upscaling of the organization and production, which will be built in Sandberg Development’s premises in Malmö.Read more
Sandberg Development invests SEK 30 million in the Malmö-based water recycling technology Company Orbital Systems.Read more
In the beginning of November reconstruction work started at our office facilites at Jägershillgatan 15 in Malmö.Read more
As part of our business concept - "Investing in innovations with growth in focus" - Sandberg Development has, during the summer, invested in an unlisted development Company, ISEC AB.Read more
New data support long-term safety and efficacy of weekly and monthly subcutaneous buprenorphine depots in patients with opioid use disorder.Read more
On April 18, 2017 the purchase deed was signed and Sandberg Development is now the owner of the property.Read more
One year after the reconstruction work started, the new production facilities were completed in March 2017.Read more
In March 2016 reconstruction and extension work started at our premises on Jägershillgatan 15 in Malmö. The first part of the reconstruction work involves the production facilities.Read more
From 2015 Sandberg Development is a sponsor of Star for Life, an educational/motivational programme, the aim of which is to strengthen the self esteem of young people and to counter the spread of HIV/AIDS.Read more
On Thursday December 3, 2015, Camurus started its first day of trading on Nasdaq Stockholm. The share price increased considerably during the first day and Camurus is now the largest company in the biotechnology sector on Nasdaq StockholmRead more
Camurus announces initial public offering on Nasdaq Stockholm. The company plans a new shares issue to a value of SEK 500 million net - a market capitalization of appr. SEK 2 billion.Read more
On November 3, 2015, Sandberg Development received Mazars prize for sustainable business. Per Sandberg was present at the prize ceremony which took place in Malmö.Read more
As of August 25, 2015 Kent Bengtsson started working as CFO in Sandberg Development.Read more
GRANULDISK recently moved into new facilities in Malmö. The history behind the large-scale investment is strong growth in Sweden and Europe and increased demand, not least from Asia and the Middle East. The company has recruited about ten new employees and expects to recruit more in the longer run.Read more
In the wake of an extensive branding process, GS Development is changing its name to Sandberg Development AB. This process was initiated to clarify its communications so that they reflect the group’s focus on world-class innovations.Read more