By Rob Curran


Shares of Ensysce Biosciences rallied after the developer of pain medication intended to be less prone to abuse received feedback from the Food and Drug Administration on clinical-trial approaches for one product.

Shares of Ensysce rose 42% to $2.04 premarket. Shares are down by more than two-thirds in the last 12 months.

The San Diego drug developer said a "constructive" meeting with FDA officials to mark the end of a Phase 2 trial of its pain medication candidate PF614 also "facilitated an affirmation" of its non-clinical program.

"We are appreciative of the guidance provided by the FDA to help us properly position PF614 as we progress through clinical trials and supporting studies in order to mitigate the risk of regulatory hurdles in our go-to market plan," said Chief Executive Lynn Kirkpatrick, in a statement.

In clinical trials so far, patients taking Ensyce's PF614 were observed to evaluate the drug's potential as a substitute for widely abused painkiller OxyContin for delivering oxycodone. Surveys evaluating patients' wish to take the drug again showed PF614 had less potential for abuse than other oxycodone products, the company said.

Ensysce is focused on pain medications that minimize the risk of both drug abuse and overdose.


Write to Rob Curran at rob.curran@dowjones.com


(END) Dow Jones Newswires

01-31-24 0921ET