Relmada Therapeutics Inc (OTCMKTS:RLMD) has seen a jump in price and volume in recent weeks after the Company has announced a number of important developments including the recent filing of Clinical Trial Application in Canada for Novel Oral Formulations of Buprenorphine.
The science behind this little known and up until recently thinly traded Company is compelling and speaks of big things to come here.
Relmada Therapeutics Inc (OTCMKTS:RLMD) is a clinical-stage specialty pharmaceutical 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 pain.
RLMD has a diversified portfolio of four lead products at various stages of development including d-Methadone, its N-methyl-D-aspartate (NMDA) receptor antagonist for neuropathic pain; MepiGel, its orphan drug designated topical formulation of the local anesthetic mepivacaine; BuTab, its oral dosage form of the opioid analgesic buprenorphine; and LevoCap ER, its abuse resistant, sustained release dosage form of the opioid analgesic levorphanol.
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 in areas of high unmet medical needs.
On February 24 RLMD announced that it has filed a Clinical Trial Application (CTA) with Heath Canada to conduct a pharmacokinetic study with novel formulations of oral, enteric-coated buprenorphine (BuTab) being developed for the treatment of both chronic moderate to moderately severe pain and opioid dependence.
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The Company is planning a Phase 1 study designed to assess the safety, tolerability, and pharmacokinetics of BuTab in healthy subjects. The safety and pharmacokinetic data from this study will inform the design of subsequent clinical pharmacology studies for opioid dependence and potential regulatory filing for this indication along with the design of a Phase 3 study in chronic pain under the abbreviated 505(b)(2) regulatory pathway.
CEO Sergio Traversa said “We continue to make progress with the development of our chronic pain relief portfolio. If we can demonstrate that BuTab compares favorably with currently marketed formulations of buprenorphine, we believe that it has significant commercial potential.”
RLMD recently announced the appointment of several leading clinicians and researchers to advisory roles; among the group were Gavril Pasternak, M.D., Ph.D., Anne Burnett Tandy Chair in Neurology at Memorial Sloan-Kettering Cancer Center and laboratory head in the Molecular Pharmacology and Chemistry Program within the Sloan-Kettering Institute.
Eric C. Strain, M.D. professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University School of Medicine and director of the Johns Hopkins Center for Substance Abuse Treatment and Research.
Andrew Rice, M.D., F.R.C.A. professor of pain research at Imperial College London is a member and previous administrative director of the London Pain Consortium, and recent chair of the IASP Special Interest Group on Neuropathic Pain.
Robert H. Dworkin, Ph.D. professor of anesthesiology at the University of Rochester School of Medicine and Dentistry and director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION).
Michael E. Thase, M.D. professor of psychiatry at the Perelman School of Medicine at the University of Pennsylvania is focused on the assessment and treatment of mood disorders, including studies of the differential therapeutics of both depression and bipolar affective disorder.
RLMD president and chief scientific officer, Eliseo Salinas, M.D., M.Sc. stated ”We are honored to have attracted this outstanding group of globally recognized experts in pain therapy to work with us. Their extensive experience and depth of knowledge in many areas directly related to our pipeline will be a significant asset for Relmada in the years ahead.”
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Currently trading at a $144 million market valuation RLMD has an outstanding balance sheet with minimal debt and $31 million dollars sitting in the treasury. The Company is making some big moves here and we will be updating on RLMD on a daily basis so make sure you are subscribed to microcapdaily.com so you know what is going on with RLMD.
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Disclosure: we hold no position in RLMD either long or short and we have not been compensated for this article.