NEW YORK, Sept 16, 2013 /PRNewswire/ -- Relmada Therapeutics Inc., a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced that has signed a collaboration agreement with the Malvern Consulting Group as clinical and regulatory advisor.
"We are particularly pleased about this positive development for Relmada as the combination of our deep expertise in the pain therapeutic space with the experience of Malvern in the regulatory and clinical development process is highly synergistic and sets a solid foundation for the success of our programs" said Sergio Traversa, CEO of Relmada Therapeutics. Relmada expects to file a company IND for d-methadone in the fourth quarter of this year and start a pivotal Phase II in diabetic painful neuropathy in 2014 with timing depending on the FDA feedback.
d-Methadone, discovered at Cornell University by Prof. Charles Inturrisi, a global authority in the pharmacology of pain therapy, is the (d) optical isomer of racemic methadone and an antagonist at the N-methyl-D-aspartate (NMDA) receptor. Unlike racemic methadone, d-methadone is practically devoid of opioid activity but maintains N-methyl- D-aspartate (NMDA) receptor antagonism. Evidence from non-clinical studies suggests that NMDA receptor antagonists can prevent the central nervous system changes that follow acute and chronic pain. Such changes are implicated in maintaining chronic pain states, especially neuropathic pain and play a role in opioid tolerance. NMDA antagonists have been shown to provide relief patients with neuropathic pain and to reduce analgesic tolerance to opioids. An open-label Phase I/IIa study at the Memorial Sloan Kettering Cancer Center showed that d-methadone was safe and well tolerated with 75% of the patients completing the study finding d-methadone to be moderately or very effective.
According to the medical literature, neuropathic pain can be difficult to treat with only half of the patients achieving partial relief, therefore representing a large market opportunity. Relmada expects that if it demonstrates analgesic efficacy, d-methadone has the potential to be a blockbuster product and compete in the neuropathic pain market which is expected to grow to $9.7 billion by 2018 according to a report by Decision Resources.
About the Malvern Consulting Group
The Malvern Consulting Group leverages its senior management's 30+ years of experience in forming companies, and developing and commercializing products to provide superior product development expertise to its clients. Malvern is comprised of a team of professionals with diverse backgrounds and expertise encompassing all disciplines of product development: pre-clinical, clinical, regulatory, quality, manufacturing, and packaging, that have achieved more than 60 approved NDAs, BLAs, MAAs and numerous 510(k)s and PMAs.
About Relmada Therapeutics
Relmada Therapeutics, Inc. is a clinical stage, private biopharmaceutical company with a diversified portfolio of four products and a deep early stage pipeline for the treatment of pain. Relmada's strategy focuses on two complementary pillars: the improvement of proven drug candidates with novel delivery methods and pharmaceutical compositions and the development of d-methadone as an innovative NMDA (N-Methyl-D-aspartate) inhibitor platform.
The Company is currently developing several drug candidates including: LevoCap ER, its abuse resistant, oncea-day sustained release dosage form of the opioid analgesic levorphanol; d-methadone, the NDMA receptor antagonist for diabetic painful neuropathy (DPN); BuCap ER, its oral sustained release dosage form of the opioid analgesic buprenorphine; MepiGel, its FDA Orphan Drug designated topical formulation of the local anesthetic mepivacaine.
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SOURCE Relmada Therapeutics, Inc.