Monthly Injectable Buprenorphine On Fast Track To Market

By Victoria Kim 11/17/16

The buprenorphine injection is designed to help treat moderate-to-severe opioid use disorder. 

Monthly Injectable Buprenorphine On Fast Track To Market

A monthly buprenorphine injection for heroin and opioid dependence will soon be submitted to the FDA for approval—after a clinical trial deemed the treatment a success.

In a joint statement released on Monday (Nov. 14), Braeburn Pharmaceuticals and Swedish pharmaceutical company Camurus AB announced that based on the trial’s success, the treatment will be submitted for approval to the Food and Drug Administration by mid-2017. 

The FDA has already granted the treatment Fast Track designation, which makes it eligible for accelerated approval.

The buprenorphine injection (called CAM2038) comes in a weekly or monthly formulation. Dr. Michelle Lofwall, primary investigator in the trial, said longer-lasting treatment modes such as the injection or the six-month implant (which was approved by the FDA in May) are better suited to improve “medication efficacy as demonstrated in this trial as well as avoiding the potential for missed or stolen doses, diversion or accidental pediatric exposure” than the daily dissolvable film strip or pill.

Cases of drug diversion—when a person takes a prescribed drug and sells or uses it illegally—have risen everywhere from prisons to schools.

The monthly or weekly injection would bypass these issues and the “stigma associated with the medication” that have arisen as a result, said Lofwall, who is a Professor of Behavioral Science and Psychiatry at the University of Kentucky Center on Drug and Alcohol Research.

Other issues with the daily medication is that people may miss or forget a dose, which may lead to a relapse and overdose. The daily medication’s effectiveness is currently limited by this poor adherence, said another researcher.

Buprenorphine can blunt opioid cravings, prevent withdrawal symptoms, and reduce the risk of relapse. The drug is the active chemical in Suboxone (a dissolvable film strip) and Zubsolv (a pill), which both also contain naloxone as an active ingredient.

According to the Wall Street Journal, approximately 650,000 Americans received buprenorphine to treat opioid addiction in 2014.

The trial studied 428 patients with opioid use disorder for six months. Participants were divided into two groups, one that received the monthly or weekly injection and one that received the daily pill. There were no reported overdoses from the group that received the injection, compared with four overdoses in the second group. (One person in the injection group died from a traffic accident.)

Researchers will present the trial’s full findings at a conference in April of next year. In the meantime, the drug makers say there are two other ongoing clinical trials to test the safety of the injection treatment.

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Victoria is interested in anything that has to do with how mind-altering substances impact society. Find Victoria on LinkedIn or Tumblr