INDVINDV

INDV's therapeutic focus is psychiatry. The company's drug, Sublocade (RBP-6000), received a Recommendation on Regulatory Action of Approval with a PDUFA Goal Date of 11/30/2017. Sublocade (RBP-6000) is proposed for the treatment of moderate to severe opioid use disorder (OUD) in patients who have undergone induction to suppress opioid withdrawal signs and symptoms with a transmucosal buprenorphine-containing product. The dosing regimen for Sublocade (RBP-6000) is 300 mg/month for two doses followed by 100 mg/month, with an option to increase to 300 mg/month.

In the Phase 3 pivotal study (13-0001), which had a duration of 24 weeks, 504 subjects were randomized. The completion rate for the RBP-6000 treatment group was >60%, while the Placebo group had a completion rate of 34%. The discontinuation rate for RBP-6000 300mg/300mg+IDC was 35.8%, and for RBP-6000 300mg/100mg+IDC it was 38.4%. In contrast, the discontinuation rate for Placebo+IDC was 66.0%, with 18% of these discontinuations due to lack of efficacy. Treatment success rates for Sublocade were 28%-29%, compared to 2% for placebo.

Other buprenorphine formulations have been approved, including a parenteral formulation in 1981, a sublingual tablet formulation in 2002, and a sublingual film formulation in 2010. A buprenorphine implantable product was approved in 2015. A Phase 2 opioid blockade study (13-0002) for Sublocade had a duration of 8 weeks.