The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend Indivior’s RBP-6000 to treat opioid use disorder.
The U.S. Food and Drug Administration (FDA)’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend Indivior’s RBP-6000 to treat opioid use disorder (OUD).
Opioid use disorder is characterized by all the indications and symptoms that reflect compulsive, prolonged self-administration of opioids for no particular medical purpose. Or, if a medical condition is present that requires opioids, they are used in excess. Given the current opioid epidemic, this is clearly a problem in the U.S. The National Survey on Drug Use and Health report said that 11.8 million Americans misused opioids in the last year. And about 2 million adults, which were classified as 12+ years old, could be classified as having OUD.
RBP-6000 is an investigational buprenorphine sustained-release formulation using the Atrigel delivery system. That system is made up of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer that is dissolved in N-methyl pyrrolidone (NMP), which is dubbed a water-miscible biocompatible solvent. After being injected, NMP seeps out of the polymer matrix and the polymer precipitates, which traps the buprenorphine inside, creating a solid depot in situ. It releases buprenorphine over a one-month period. More to the point, after injection, it allows the drug to stay in your body and slowly release itself over 30 days.
The drug met its primary endpoint in the Phase III study, which were higher abstinence rates compared to placebo. The abstinence rates on the 300mg/300 mg dosages was 41.3 percent compared to 5 percent on the placebo, and at the 300 mg/100mg dosages, was 42.7 percent compared to placebo.
The drug was generally well tolerated. Side effects were usually a reaction at the injection site, and resulted in less than 1 percent of patients ending treatment. Otherwise, the most common side effects reported were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzyme, fatigue and pain at the injection site.
“The Advisory Committees’ favorable recommendation of RBP-6000 moves us one step closer to potentially bringing this once-monthly injectable buprenorphine treatment option to patients struggling with opioid use disorder,” said Shaun Thaxter, Indivior’s chief executive officer, in a statement. “We are committed to pioneering new options for patients living with this chronic, yet treatable disease to help address the nation’s growing opioid epidemic.”
The committee’s vote isn’t binding, but the FDA usually follows the recommendations. The FDA will make a decision on whether to approve the drug by Nov. 30, 2017.
Indivior stock jumped at the news. Shares traded for 345.30 pence sterling ($4.59 US) on Oct. 30, and are currently trading at 404.20 pence sterling ($5.37 US), an increase of around 33 percent.
Numis Securities reiterated its “buy” rating for Indivior early this week, with a price target of $6.60. Citigroup restated a “neutral” rating with a price target of $3.69 last Thursday, Oct. 26. Stifel Nicolaus reiterated “buy” with a price target of $5.28 on Sept. 15, and Jefferies Group cut their price target from $7.13 to $4.72 with a “buy” on Sept. 8.
