Relmada Therapeutics Announces Notice of Allowance for U.S. Patent Covering SECUREL(TM), its Abuse-Deterrent, Extended-Release, Technology Platform for Opioids
The Company's LevoCap ER is the First Product Candidate Utilizing the SECUREL Technology Platform
NEW YORK, May 12, 2015 /PRNewswire/ -- Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced that Application No. 12/597,702 relating to its proprietary SECUREL abuse deterrent technology platform was allowed for issuance as a new patent by the U.S. Patent and Trademark Office (USPTO).
The new SECUREL patent application is entitled "Multimodal Abuse Resistant and Extended Release Opioid Formulations." Once granted, the patent is expected to be valid until at least 2028. Relmada's lead development program, LevoCap ER (REL-1015, levorphanol extended-release, abuse deterrent capsules), is the first product candidate utilizing the SECUREL technology platform. The patent contains claims that provide broad coverage for levorphanol and other opioids that could leverage the SECUREL technology platform.
"These newly allowed claims strengthen Relmada's overall patent portfolio," said Sergio Traversa, CEO of Relmada Therapeutics. "With this new patent protection and levorphanol's broad spectrum activity, LevoCap ER could be well positioned commercially in the chronic pain treatment market, if approved. We look forward to initiating a Phase III study with LevoCap ER as soon as feasible following interactions with the Food and Drug Administration (FDA) with respect to the end of Phase 2 meeting expected to take place before the end of 2015."
Recent experience with extended release opioid pain relievers has shown that intentional crushing or extraction of the active ingredient from the dosage form by addicts and recreational drug users can destroy the timed-release mechanism and result in a rapid surge of drug into the bloodstream. Serious side effects and death have been reported from such misuse.
SECUREL is Relmada's proprietary abuse deterrent extended release technology for opioid drugs. SECUREL dosage forms cannot be easily crushed for inhalation or to obtain rapid euphoria from high blood levels when swallowed. It is also exceedingly difficult for I.V. abusers to extract the active drug from the dosage form using common solvents, including alcohol.
About LevoCap ER
LevoCap ER is an extended release, abuse resistant form of levorphanol, which is pharmacologically differentiated from morphine, oxycodone, and other strong opioids being studied for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. In particular, levorphanol binds to all three opioid receptor subtypes involved in analgesia (mu 1, kappa and delta), the N-methyl-D-aspartate (NMDA) receptor and the norepinephrine and serotonin uptake pumps, whereas morphine is relatively selective for mu sites. Due to the selectivity of morphine for mu receptors compared to levorphanol's ability to interact more potently with other relevant receptor subtypes, levorphanol could achieve analgesia in patients resistant to other strong opioids.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded 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. The Company has a diversified portfolio of four lead products at various stages of development including d-Methadone (REL-1017) its N-methyl-D-aspartate (NMDA) receptor antagonist for neuropathic pain; topical mepivacaine (REL-1021), its orphan drug designated topical formulation of the local anesthetic mepivacaine; oral buprenorphine (REL-1028) its oral dosage form of the opioid analgesic buprenorphine; and LevoCap ER (REL-1015), 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. For more information, please visit Relmada's website at: www.relmada.com.
This news release contains "forward-looking statements." These statements are based on management's current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Michael Becker, SVP of Finance and Corporate Development
Relmada Therapeutics Inc.
Berry & Company Public Relations
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SOURCE Relmada Therapeutics, Inc.
Released May 12, 2015