PainReform wins US FDA's approval for Phase III post-operative pain relief study of PRF-110.
M2 PHARMA-July 19, 2018-PainReform wins US FDA's approval for Phase III post-operative pain relief study of PRF-110
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Pharmaceutical company PainReform Ltd reported on Wednesday the receipt of approval from the US FDA to launch two pivotal Phase III clinical trials of of PRF-110 for post-operative pain relief in soft and hard tissue.
Headquartered in Herzliya, Israel, the company is currently raising USD15m to conduct the trials.
The company said PRF-110 is an extended release version of ropivacaine providing longer relief of post-surgical incision pain. PRF-110 has the complete set of attributes, including efficacy, safety, physical properties and low-cost, to position it as the leading candidate in this very large pain relief drug market. The estimated market potential for pain relief drugs is USD5bn.
Both the pivotal Phase III clinical trials will use the company's PRF-110, a proprietary extended release version of ropivacaine (Naropin) that provides long relief of post-surgical incision pain.
Under a prior Phase II study, PRF-110 demonstrated pain relief for up to 72 hours, which is ten times longer than the current standard of care, concluded the company.
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|Date:||Jul 19, 2018|
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