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. [5]

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. [4]

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. [6]

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. [7]Of these, 230,000 had used heroin. [7]In 2016, 1,808 drug-induced deaths were registered in Australia, the highest number of drug deaths in 20 years. [8] On a sample day in 2017, approximately 50,000 people in Australia received pharmacotherapy treatment for opioid dependence. [9]

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.[4] 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, Buvidalis 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.

About Camurus
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.