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FDA accepts NDA for RBP-6000 for opioid addiction
Indivior recently announced that the FDA accepted its New Drug Application for RBP-6000, an investigational once-monthly injectable buprenorphine treatment, with a priority review designation for moderate-to-severe opioid use disorder.
“FDA acceptance with a priority review designation of our [New Drug Application] for RBP-6000 represents a significant milestone for our company as well as for the broader field of opioid use disorder treatment,” Shaun Thaxter, CEO of Indivior, said in a press release. “This milestone is the result of our clear focus on developing treatments that deliver on the unmet needs of patients, along with our relentless advocacy for evidence-based medication-assisted treatment as a key part of the addiction recovery equation.”
The New Drug Application, submitted in May 2017, was based on data from a phase 3 study.
To determine safety and efficacy of RBP-6000 for moderate-to-severe opioid use disorder, researchers conducted a randomized study among 504 treatment-seeking adults, aged 19 to 54 years, with moderate or severe opioid use disorder not currently receiving medication-assisted treatment. Study participants were randomly assigned to receive two dosages of RBP-6000 (n = 404) or placebo (n = 100).
Prior to randomization, participants were inducted and dose-stabilized on transmucosal buprenorphine product to suppress opioid withdrawal symptoms and confirm lack of buprenorphine allergy. Suboxone (buprenorphine/naloxone, Indivior) sublingual film was used for induction. Supplemental dosing with any buprenorphine-containing product was not permitted after randomization.
Study participants received six once-monthly 300-mg doses, two once-monthly 300-mg doses followed by four once-monthly 100-mg doses, or six once-monthly subcutaneous injections of placebo for 24 weeks. All participants received manual-guided psychosocial support at least once a week.
Abstinence rates were significantly higher among participants who received 300 mg of RBP-6000 (41.3%) and 300 mg/100 mg of RBP-6000 (42.7%), compared with placebo (5%; P < .0001).
Participants who received 300 mg (29.1%) and 300 mg/100 mg of RBP-6000 (28.4%) were more likely to test negative on at least 80% of urine samples and report negative illicit opioid use, compared with placebo (2%; P < .0001).
Serious treatment-emergent adverse events occurred among 2.7% of participants who received RBP-6000, compared with 5% who received placebo.
Severe treatment-emergent adverse events occurred among 6.9% of participants who received RBP-6000, compared with 4% who received placebo.
The most common treatment-emergent adverse events were headache, constipation, nausea, injection site pruritus, vomiting, insomnia and upper respiratory tract infection.
The FDA set a Prescription Drug User Fee Act target action date of November 30, 2017.
Further, the FDA notified Indivior that the New Drug Application for RBP-6000 will be reviewed at an Advisory Committee meeting, projected to convene in Q4 of 2017.
“We are excited about FDA’s acceptance with priority review designation of our [New Drug Application] for RBP-6000, which we believe will represent an entirely new treatment paradigm if approved,” Christian Heidbreder, PhD, chief scientific officer of Indivior, said in the release. “We look forward to continuing to work closely with the agency as they review our New Drug Application and bring this potential innovative treatment option to patients and physicians.” – by Amanda Oldt
Reference:
Learned S, et al. RBP-6000 buprenorphine monthly depot demonstrates efficacy, safety, and exposure/response relationship in opioid use disorder. Presented at: College on Problems of Drug Dependence Annual Meeting; June 17-22, 2017; Montreal.