Avenue Therapeutics, Inc. ATXI announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), through which it is seeking approval for its pipeline candidate intravenous (IV) tramadol. The NDA was filed for the candidate to manage moderate-to-moderately severe post-operative pain in a medically supervised health care setting.
Shares of Avenue Therapeutics plunged almost 59% on Monday following the announcement of the CRL as it may delay tramadol’s approval. The stock has lost 52.8% so far this year compared with the industry ’s decline of 4.6%.
The CRL issued by the regulatory authority raised one safety concern. The FDA stated that IV tramadol, which is intended to treat patients in acute pain who require an opioid is not safe for the targeted patient group. The CRL stated that IV tramadol will likely increase the likelihood of opioid-related adverse effects due to possible requirement of two opioid analgesics, one between the first dose of IV tramadol and the onset of analgesia, and another is a rescue analgesic. Moreover, the FDA requested an adequate terminal sterilization validation prior to the NDA approval.
Notably, the NDA for IV tramadol was submitted based on positive data from two pivotal studies evaluating the candidate in patients following bunionectomy and abdominoplasty surgeries.
Data from the studies demonstrated that administration of the candidate achieved a statistically significant improvement in pain intensity as measured by the Sum of Pain Intensity Difference over 48 hours versus placebo. Moreover, data from one study also showed that the candidate has similar efficacy and safety to that of IV morphine, a standard-of-care IV opioid.
The company believes that IV tramadol lessens the potential of abuse and lowers the risk of dependence, and will likely be an effective alternative to intravenous Schedule II conventional opioids. The company is planning to meet the FDA officials to discuss the CRL as soon as possible to resolve the issues. We note that a potential approval will lend a significant boost to the company. There is a great need for safe, effective and non-addictive options that can decrease opioid exposure, given the epidemic of opioid abuse that put companies like J&J JNJ , Endo International ENDP and Mallinckrodt MNK among others under the microscope.
Zacks Rank
Avenue Therapeutics currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
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