Tharimmune (THAR) said Monday the US Food and Drug Administration has advised that no additional clinical trials are required to support a new drug application for TH104 as a prophylaxis against opioid exposure.
The company said the FDA's feedback is based on existing data on nalmefene, the approved active ingredient embedded in TH104, including its safety profile and efficacy against opioid overdose as well as Tharimmune's pharmacokinetic data to support an "in silico" submission.
Tharimmune said it is seeking to develop TH104 for the additional proposed indication of "temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids."
The company is developing TH104 for the proposed indication of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis.
Tharimmune shares rose over 5% in recent Monday trading.
Price: 1.44, Change: +0.07, Percent Change: +5.18
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