Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), announced the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy subjects. Feedback from FDA was obtained on the study protocol, and the non-objection letter was received on July 12th from Health Canada. The First-Subject, First-Dose was administered on July 26th. The PK study is the next step in the proposed 505(b)(2) regulatory pathway for GTX-101. This study is expected to be completed by the end of calendar 2022 as planned and will provide important information on the dose and dosing frequency in humans.
GTX-101 is a novel formulation of bupivacaine hydrochloride (HCl) for topical administration via a bio-adhesive, film-forming polymer, for relief of pain associated with Postherpetic Neuralgia (PHN), a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles), which may persist for months and even years.
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