PainReform's Phase 3 Trial Of PRF-110 Delayed Due To Supplier Issue

(RTTNews) - Shares of PainReform Ltd. (PRFX), a clinical-stage specialty pharmaceutical company, slipped nearly 14% in after-hours trading on Wednesday, after a supplier issue has delayed its phase 3 clinical trial of PRF-110 in patients undergoing bunionectomy surgery.

The company's supplier of the API (active pharmaceutical ingredient) received a deficiency notice from the FDA related to its Drug Master File (DMF). The DMF is the file on record with the FDA representing the manufacturing process and facility for the production of the API.

As a result, the second part of the phase 3 trial is expected to commence once the required information has been provided by the supplier to the FDA and the deficiency notice has been resolved.

Ilan Hadar, Chief Executive Officer of PainReform, stated, "Although we encountered what will likely be a delay in starting the second part of the Phase 3 trial, we are working closely with our API supplier to ensure the matter is resolved in the most expedient manner possible. These circumstances were out of our control, but we believe our supplier is taking the necessary steps, which should enable us to commence the second part of the trial in as short a timeframe as possible. We look forward to providing near-term updates about the timeline as soon as practicable."