British drugmaker Indivior got the green light from US regulators to sell its schizophrenia drug Perseris — a relief, no doubt, considering the company’s ongoing exclusivity war over its staple drug Suboxone.
This newly approved medicine, which used to be called RBP-7000, is a long-acting injectable delivered under the skin once per month. The drug contains risperidone, a go-to treatment for schizophrenia that’s already FDA approved. But Indivior’s version uses an extended release delivery system to form a depot that provides sustained levels of the drug over the course of the month. The hope, Indivior says, is to help boost patients’ adherence to taking the drug.
Perseris comes with a black box warning, however, which notes that elderly patients with dementia-related psychosis could suffer from increased mortality risk.
The approval of Perseris puts one new arrow in Indivior’s quiver, and it couldn’t be more welcome considering Indivior’s main cash cow — the opioid addiction drug Suboxone — is in jeopardy of generic competition.
The company’s stock (LON: INDV) has been hit by the continued threat of Indian drugmaker Dr. Reddy’s making a generic version of Suboxone. A preliminary injunction stopped Dr. Reddy’s from selling its generic version of the drug. But recently, Dr. Reddy’s appealed the ruling and filed emergency motions to expedite the appeal of the preliminary injunction and to stay the ruling pending a decision on the appeal. Under the new schedule, the companies are due to make their cases in October.
And that threat is looming over Indivior, casting a shadow on its new drug approval for Perseris. In its latest financial statements, Indivior couldn’t provide earnings guidance for the year while the matter remained open, and the company noted that generic competition had significantly cut into its US market share.
In light of all the drama and uncertainty around Suboxone, Indivior said it would “review the appropriate launch timing for Perseris.” They did say, however, that the drug would be launched as soon “as reasonably practicable.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 51,100+ biopharma pros who read Endpoints News by email every day.Free Subscription