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PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. Its proprietary drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while also reducing the use of opiates commonly administered after surgery.
The companys strategy is to incorporate generic drugs which have been proven safe and effective with its proprietary extended-release drug-delivery system in order to create a major improvement in therapy via extended-release drug products and to take advantage of the 505(b)(2) regulatory pathway created by the U.S. Food and Drug Administration (FDA).
The 505(b)(2) new drug application process provides for FDA approval of a new drug based in part on data developed by others, including references in published literature and data previously reviewed by the FDA in its approval of a separate application. This pathway can significantly reduce future time and costs associated with clinical development.
PainReforms first product, PRF-110, is based on the local anesthetic ropivacaine and is designed to target the post-operative pain relief market.