Feb 23 (Reuters) - KemPharm Inc said on Friday 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 last year after appealing against the drug regulator’s decision to reject it in 2016.
The FDA had said intranasal abuse of the opioid-based product was a relevant concern.
KemPharm said the Drug Enforcement Administration (DEA) intends to schedule Apadaz as a C-II product. A C-II drug is considered to have a high potential for abuse, according to the DEA’s website.
Investors have been skeptical about the drug’s approval, considering Apadaz’s regulatory issues in the past.
The company’s shares have risen 50 percent in the past 12 months and were trading at $4.95 in late afternoon trading on Friday.
Reporting by Anuron Mitra and Manas Mishra in Bengaluru; Editing by Arun Koyyur