FDA staff says AcelRx opioid painkiller is not better than rivals
(Reuters) – AcelRx Pharmaceuticals Inc’s opioid painkiller offers no apparent advantage to currently available therapies, staff reviewers of the U.S. Food and Administration said on Wednesday.
The FDA staff also highlighted that the small size of the oral Dsuvia pills makes it easier for patients to misplace them, potentially resulting in accidental use by others.
The drug is a new formulation that is meant to be taken orally through a pre-filled, single-dose applicator.
An advisory panel to the FDA will vote on the drug on Friday, before the regulator’s final decision by Nov. 3. The regulator generally follows the advice of its experts, but is not obliged to do so.
Reporting by Manas Mishra and Aakash Jagadeesh Babu in Bengaluru; Editing by Saumyadeb Chakrabarty