Relmada Therapeutics Secures First European Patent Covering LevoCap ER

Relmada Therapeutics, Inc. recently announced it has been granted a patent from the European Patent Office (EPO) for compositions and methods of use for its extended release oral levorphanol (3-hydroxy-N-methylmorphinan). The Patent (EP 2 448 406 B1), titled Extended Release Oral Pharmaceutical Compositions of 3-hydroxy-N-methylmorphinan broadly covers Relmada’s SECUREL technology platform and LevoCap ER (REL-1015, levorphanol extended-release, abuse-deterrent capsules). The patent is not scheduled to expire until 2030.

“This new patent is Relmada’s first European patent providing exclusivity for LevoCap ER and significantly strengthens the company’s overall patent portfolio and supports our continuing development program,” said Sergio Traversa, CEO of Relmada Therapeutics. “The issuance of this patent also further increases the value proposition of our pain therapy franchise and positions the Company better for strategic partnering opportunities.”

LevoCap ER is an extended-release, abuse-resistant form of levorphanol, which is pharmacologically differentiated from morphine, oxycodone, and other strong opioids. LevoCap ER is being developed 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 sites, whereas morphine is relatively selective for mu sites. Due to these multiple activities, levorphanol could achieve analgesia in patients resistant to other strong opioids.

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 IV abusers to extract the active drug from the dosage form using common solvents, including alcohol.

Relmada Therapeutics is a clinical-stage, publicly traded 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, visit www.relmada.com.