PainReform Ltd, developer of a proprietary reformulation technology, has received approval from FDA to conduct two pivotal Phase III clinical trials for post-operative pain relief in soft and hard tissue, it was reported yesterday.
The trials will utilise PRF-110, a proprietary extended release version of ropivacaine (Naropin), which offers long relief of post-surgical incision pain. In a Phase II study, the product demonstrated pain relief for up to 72 hours, ten times longer than the current standard of care. PainReform is currently raising USD15m to conduct the trials.
PRF-110 has undergone extensive preclinical testing of both safety and extended analgesic efficacy, a Phase I study using an experimental pain model in healthy volunteers and a Phase II efficacy study in postsurgical hernia patients.
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