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news.Compass Point Research has entered into an agreement with NDA Partners for the development of a new combination drug to treat migraine headaches.
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The drug sponsor, MultiCorp International, has retained Compass Point to manage the product development program.
Under the deal, NDA Partners will provide the drug development and regulatory expertise needed to prepare a development plan for a 505(b)(2) NDA submission to the US Food and Drug Administration (FDA).
NDA Partners will also be responsible for managing a preIND meeting with the FDA review division.
The product is a combination of two FDA approved drugs, diphenhydramine (Benadryl) and trimethobenzamide (Tebamide, Tigan).
The company said that diphenhydramine is clinically used in combination with other dopamine antagonists such as prochloperazine and metoclopramide as first line therapy to treat migraine headaches, while trimethobenzamide is an antiemetic used to prevent nausea and vomiting.
The drug combination, delivered as a single injection intramuscularly, showed pain relief, tolerability and efficacy at 24 hours compared to subcutaneous sumatriptan, in an emergency department-based clinical trial conducted in 2005.