KemPharm Inc said the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain.
The company resubmitted the drug’s marketing application for review in September after appealing against a rejection by the drug regulator in 2016 on concerns of opioid abuse.
KemPharm said Apadaz is likely to be scheduled as a C-II product – a drug with a high potential for abuse.
“It’s a product that has differentiation, but not the traditional abuse-deterrent claims,” KemPharm’s Chief Executive Officer Travis Mickle told Reuters.
Mickle said the company would try new ways to sell the drug without an abuse-deterrent label.
The company, which expects to produce close to 5 billion tablets a year, said it would try to establish either a non-traditional pact with a pharmacy benefit manager or a tie-up with a generic pharmaceutical company.
“We are in active discussions on both approaches,” Chief Operating Officer Gordon Johnson said on a conference call.
KemPharm is planning to price Apadaz close to low-cost generic products as many drugmakers such as Egalet Corp and Collegium Pharmaceuticals have opioid-based branded drugs with an abuse-deterrent label.
“The generics are cheap and people are going to continue using them over some sort of branded molecule that’s going to cost a lot more,” Oppenheimer analyst Derek Archila told Reuters.
(Reporting by Anuron Mitra and Manas Mishra in Bengaluru; Editing by Arun Koyyur)