(RTTNews) – Shares of Avenue Therapeutics, Inc. (ATXI) more-than-halved on Monday morning after the FDA said it can’t approve Tramadol’s NDA in its present form.
ATXI is currently trading at $4.87, down $6.17 or 55.8877%, on the Nasdaq.
Avenue Therapeutics, a company focused on the development of intravenous tramadol for the U.S. market, said it received a Complete Response Letter from the U.S. Food and Drug Administration regarding the company’s New Drug Application for IV tramadol.
The CRL stated that although the pivotal Phase 3 clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA has determined that it cannot approve the application in its present form.
FDA’s response stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population.
The CRL stated that the FDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter.
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