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Nuedexta

Otsuka Holdings Co., Ltd.

Drug Names(s): BIO-3010, Neurodex, dextromethorphan and quinidine [DM/Q], DMQ, Zenvia, AVP-923

Description: Zenvia is a patented, orally administered combination of two approved drugs: dextromethorphan (DM), which is an NMDA glutamate receptor antagonist (glutamate is an excitatory neurotransmitter) and sigma 1 agonist (suppressing the release of excitatory neurotransmitters) sold over-the-counter as a cough suppressant, and quinidine, which in this case acts as an cytochrome P450 (CYP2D6) inhibitor that sustains elevated levels of DM in the human body.

Deal Structure: IriSys
In August 2000, AVANIR Pharmaceuticals announced completion of a license agreement for exclusive worldwide rights to AVP-923 for the treatment of multiple central nervous system disorders including emotional lability, neuropathic pain and chronic cough. The product was licensed from IriSys Research and Development.

With regards to the license agreement, there are no upfront payments by AVANIR. Milestone payments would be made only upon FDA's acceptance of the filing of an NDA and for FDA marketing approvals for each indication. If AVANIR is successful in obtaining FDA approval and market the drug, it would pay a royalty based on product sales. AVANIR is obligated to use commercially reasonable efforts to develop and commercialize two potential indications for AVP-923, including funding of all development costs.

Center for Neurologic Study
In March 2005, Avanir entered into an Asset Purchase Agreement, pursuant to which its wholly owned subsidiary,...See full deal structure in Biomedtracker


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