Camurus AB (publ) and its U.S. partner Braeburn Inc.'s opioid use disorder treatment Brixadi was granted tentative approval by the U.S. Food and Drug Administration.
Brixadi is an extended-release injection given under the skin that is used to treat patients who are receiving buprenorphine, the current standard of care for opioid withdrawal.
Sweden-based Camurus said the final approval of a monthly dosage of the drug will be granted by the FDA once the exclusivity period granted to Indivior PLC's Sublocade, also an extended-release buprenorphine, comes to an end.
Camurus said the restriction period may not last longer than November 2020 and could be reduced if successfully challenged. India's Dr. Reddy's Laboratories Ltd. has been in a legal tussle with Indivior to launch a generic version of Suboxone.
Brixadi, which will be available in weekly and monthly formulations, works by releasing buprenorphine at a steady rate, blocking the so-called drug-liking effect of opioids in the brain and reducing withdrawal and drug-craving symptoms, thus reducing the likelihood that patients will take illicit opioids.
The U.S. FDA's decision was based on positive data from seven clinical trials showing the efficacy and safety of Brixadi. It follows the European approval of the same drug, known as Buvidal outside the U.S., to treat opioid dependence in people aged 16 years and older.
Treatments for opioid use disorder, which affects more than 2 million Americans and caused at least 72,000 overdose deaths in 2017, has received urgent attention from the FDA. In December, Novartis AG's and Pear Therapeutics Inc.'s reSET-O became the first prescription digital therapeutic approved by the U.S. regulator to treat opioid use disorder, while in November, eight medical device companies, ranging from therapeutics to diagnostic capabilities, were selected by the FDA for their submitted development plans to help combat the opioid crisis.
However, there has been a debate on the efficacy of extended-release opioid treatments. In October, the U.S. pricing watchdog the Institute for Clinical and Economic Review found that the cost of treatments for opioid use disorder far exceeds its thresholds for cost-effectiveness. ICER also found insufficient evidence that extended-release medications provide a greater net health benefit than buprenorphine and naloxone.