October 10, 2018 / 12:43 PM / a month ago

CORRECTED-FDA staff says AcelRx opioid painkiller safe and effective

(Corrects headline and first paragraph to say AcelRx opioid was safe and effective for use, not that the painkiller offers no apparent advantage to currently available therapies; removes quote from third paragraph)

Oct 10 (Reuters) - AcelRx Pharmaceuticals Inc’s opioid painkiller was safe and effective for use based on resubmitted data, staff reviewers of the U.S. Food and Administration said on Wednesday.

The FDA staff reviewers, however, said remain concerns regarding the risk of misplaced tablets, which could lead to accidental exposure.

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)

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