Ensysce Biosciences experienced a surge in shares after receiving feedback from the Food and Drug Administration (FDA) regarding clinical-trial approaches for one of their pain medication products. The San Diego-based drug developer’s stock rose by 42% to $2.04 premarket, marking a significant improvement after a period of decline in the past year.

Following the successful completion of Phase 2 trials for their pain medication candidate, PF614, Ensysce Biosciences held a “constructive” meeting with FDA officials. This meeting not only marked the end of the trial but also served as an affirmation of the non-clinical program the company had implemented.

Chief Executive Lynn Kirkpatrick expressed gratitude for the FDA’s guidance in positioning PF614 during the upcoming clinical trials and supporting studies. The aim is to mitigate any potential regulatory hurdles that may arise in the company’s go-to-market plan.

During the initial clinical trials, PF614, which was designed as an alternative to the widely abused painkiller OxyContin for delivering oxycodone, demonstrated promising results. Patient surveys indicated that PF614 had a lower potential for abuse compared to other oxycodone products. Ensysce Biosciences remains committed to developing pain medications that minimize both drug abuse and overdose risks.

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