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Tuesday, November 29, 2022

A Look at Relmada Therapeutics Inc (OTCMKTS:RLMD)

Relmada Therapeutics Inc (OTCMKTS:RLMD) is back under $3 after the recent move the stock made to a high of $4 a share.

The stock was recently subject to a hard mailer promotion from Gramercy Strategic Partners LLC with a disclosed budget of $964,391; the mailer is made to look like a newspaper mockup.

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.

On March 24 RLMD announced it has received a No Objection Letter (“NOL”) from Health Canada to conduct the first pharmacokinetic study with novel formulations of oral, enteric-coated buprenorphine (BuTab, REL-1028) being developed for the treatment of both chronic pain and opioid dependence.

CEO Sergio Traversa remarked “Following Health Canada clearance, our second product candidate is about to enter clinical trials during the second quarter of 2015. The rapid progress of our pain relief portfolio this year is a testament to the experienced and talented team we have in place at Relmada Therapeutics. If we can demonstrate that oral BuTab compares favorably with currently marketed sublingual formulations of buprenorphine, we believe that it has significant commercial potential.”

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.

According to RLMD Buprenorphine has been widely used in several different formulations, but not by the more traditional oral capsule/tablet route due to historically poor oral bioavailability. Relmada’s BuTab product candidate is designed to overcome this limitation by avoiding the metabolism that normally occurs in the upper gastrointestinal tract, therefore allowing it to be absorbed into the bloodstream. Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Buprenorphine is a mu-opioid receptor partial agonist and a potent analgesic with a relatively long duration of action.

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Currently trading at a $147 million market valuation RLMD has an outstanding balance sheet with minimal debt and $31 million dollars sitting in the treasury. The stock recently ran big on the Gramercy Strategic Partners $964,391 mailer promotion but has dropped to where it started since. 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.

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