Relmada Therapeutics’ (OTCQB: RLMD) shares are up 20% mid-day after the company said that it has received Fast Track designation for d-Methadone from the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder. This designation offers many advantages, including more frequent meetings and written communications with the FDA, accelerated review and priority approval, and rolling New Drug Application review. “The designation of Fast Track status by the FDA is further validation of the potential for d-Methadone to represent a major advance in treatment that can help patients with inadequate response to the current standard of care. We look forward to working with the FDA to advance the development program for d-Methadone and an expedited regulatory process,” Chief Scientific Officer Richard Mangano, Ph.D. stated in the news release.
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About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company developing novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. The company has a diversified portfolio of four products at various stages of development, including d-Methadone (dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist for depression and neuropathic pain; LevoCap ER (REL-1015), an abuse resistant, sustained release dosage form of the opioid analgesic levorphanol; oral buprenorphine (BuTab, REL-1028), an oral dosage form of the opioid analgesic buprenorphine; and topical mepivacaine (MepiGel, REL-1021), an orphan drug designated topical formulation of the local anesthetic mepivacaine. The company’s product development efforts are guided by the internationally recognized scientific expertise of its research team. The company’s approach is expected to reduce clinical development risks and costs while potentially delivering valuable products to address areas of high unmet medical needs. For more information, please visit Relmada’s website at: www.relmada.com.
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