d-Methadone is Expected to Enter Proof of Concept Phase 2 Clinical Development in the First Half of 2016
NEW YORK, NY, USA I July 27, 2015 I Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced that it has filed a Clinical Trial Application (CTA) with Heath Canada to conduct a multiple ascending dose (MAD) clinical study with d-Methadone (dextromethadone, REL-1017), its novel, N-methyl-D-aspartate (NMDA) receptor antagonist being developed for the treatment of neuropathic pain.
“We are very encouraged by the initial results from our completed single ascending dose study that successfully demonstrated a lack of dose limiting side effects with d-Methadone – even when administered at doses several fold higher than conventionally used with racemic methadone in opioid naïve subjects,” stated Sergio Traversa, CEO of Relmada Therapeutics. “Assuming successful completion of the multiple ascending dose study, d-Methadone should enter Phase 2 proof of concept clinical development in the first half of 2016.”
The aim of the completed study was to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of oral single ascending doses of d-Methadone in healthy subjects in order to establish a Maximum Tolerated Dose (MTD). In the planned second study, healthy subjects will receive daily doses of the product over several days based on the established MTD. The data from these studies will inform the design of a subsequent Phase 2 proof of concept study in neuropathic pain.
About d-Methadone (dextromethadone, REL-1017)
As a single isomer of racemic methadone, d-Methadone (dextromethadone, REL-1017) has been shown to possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses. The activation of NMDA receptors has been associated with neuropathic pain and it is expected that d-Methadone will have a role in pain management by blocking this activity. In contrast, racemic methadone is a long-acting narcotic producing typical opioid side effects used in the treatment of various pain states and as a substitution therapy in opioid addiction.
About Neuropathic Pain
Neuropathic pain is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The term neuropathic pain is used to describe a wide range of pain syndromes, including painful diabetic neuropathy, postherpetic neuralgia, and trigeminal neuralgia. According to the Neuropathy Association, neuropathic pain is estimated to affect more than 20 million people in the United States alone. The main classes of drugs used to treat neuropathic pain conditions are anticonvulsants, antidepressants, opioids, and topical treatments. However, despite the availability of multiple pain medications only about 50% of patients respond to treatment with currently available therapy options, and many present the risk of numerous side effects that reduce their tolerability.
About Relmada Therapeutics
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.
SOURCE: Relmada
Post Views: 69
d-Methadone is Expected to Enter Proof of Concept Phase 2 Clinical Development in the First Half of 2016
NEW YORK, NY, USA I July 27, 2015 I Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced that it has filed a Clinical Trial Application (CTA) with Heath Canada to conduct a multiple ascending dose (MAD) clinical study with d-Methadone (dextromethadone, REL-1017), its novel, N-methyl-D-aspartate (NMDA) receptor antagonist being developed for the treatment of neuropathic pain.
“We are very encouraged by the initial results from our completed single ascending dose study that successfully demonstrated a lack of dose limiting side effects with d-Methadone – even when administered at doses several fold higher than conventionally used with racemic methadone in opioid naïve subjects,” stated Sergio Traversa, CEO of Relmada Therapeutics. “Assuming successful completion of the multiple ascending dose study, d-Methadone should enter Phase 2 proof of concept clinical development in the first half of 2016.”
The aim of the completed study was to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of oral single ascending doses of d-Methadone in healthy subjects in order to establish a Maximum Tolerated Dose (MTD). In the planned second study, healthy subjects will receive daily doses of the product over several days based on the established MTD. The data from these studies will inform the design of a subsequent Phase 2 proof of concept study in neuropathic pain.
About d-Methadone (dextromethadone, REL-1017)
As a single isomer of racemic methadone, d-Methadone (dextromethadone, REL-1017) has been shown to possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses. The activation of NMDA receptors has been associated with neuropathic pain and it is expected that d-Methadone will have a role in pain management by blocking this activity. In contrast, racemic methadone is a long-acting narcotic producing typical opioid side effects used in the treatment of various pain states and as a substitution therapy in opioid addiction.
About Neuropathic Pain
Neuropathic pain is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The term neuropathic pain is used to describe a wide range of pain syndromes, including painful diabetic neuropathy, postherpetic neuralgia, and trigeminal neuralgia. According to the Neuropathy Association, neuropathic pain is estimated to affect more than 20 million people in the United States alone. The main classes of drugs used to treat neuropathic pain conditions are anticonvulsants, antidepressants, opioids, and topical treatments. However, despite the availability of multiple pain medications only about 50% of patients respond to treatment with currently available therapy options, and many present the risk of numerous side effects that reduce their tolerability.
About Relmada Therapeutics
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.
SOURCE: Relmada
Post Views: 69
