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Pharmaceuticals / Submissions and Approvals

Relmada Wins FDA Fast Track Designation for d-Methadone

April 21, 2017
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Relmada Therapeutics received an FDA fast track designation for d-Methadone (REL-1017 dextromethadone), a receptor antagonist in development for the adjunctive treatment of major depressive disorder.

REL-1017 is a new chemical entity being developed as an oral agent for the treatment of depression, neuropathic pain and other potential CNS pathological conditions. The company has completed Phase I single and multiple ascending dose studies and has confirmed safety, tolerability and dose range for planned Phase II studies in treatment-resistant depression.

Relmada is planning a Phase IIa placebo-controlled study in patients with major depressive disorder, assessing changes in depressive symptoms as well as the safety, tolerability and pharmacokinetics of two dose levels of REL-1017.

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