Privately-held pain specialist Neumentum has progressed both its new, non-opioid, lead product candidates through interactions with the US Food and Drug Administration (FDA).
The Californian company has agreed a Type C meeting for October relating to NTM-006, its oral new chemical entity with a new mechanism of action targeting neuropathic pain. Phase IIa data in moderate-to-severe pain show significantly superior efficacy of NTM-006 to acetaminophen 1000mg at study endpoints, and longer duration of analgesia.
Based on a recent FDA guidance letter, Neumentum believes there is clear understanding of the regulatory path forward for NTM-001, a Phase III-ready potent non-steroidal anti-inflammatory drug (NSAID) targeting moderately severe post-surgical pain. This formulation of Toradol (ketorolac tromethamine) has the potential to be the first NSAID ever approved for the US market for continuous infusion.
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