NEW YORK, NY, USA I December 9, 2015 I Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced topline results of a proof-of-concept pharmacokinetic study in healthy volunteers using its BuTab (REL-1028), an investigational, oral formulation of buprenorphine, an opioid that is broadly used to treat both addiction and chronic pain. BuTab is designed to be delivered orally and reach safe and effective blood levels of buprenorphine through the gastrointestinal route of administration due to its modified release profile. There are currently no commercially available oral formulations of buprenorphine that result in gastrointestinal absorption.
“We are very pleased with this BuTab trial results as we have demonstrated for the first time that buprenorphine can be delivered at therapeutic level through the gastrointestinal route,” said Sergio Traversa, CEO of Relmada Therapeutics. “This opens the way for the successful development of a first in class orally delivered buprenorphine product, eagerly awaited in the market place.”
Dr. Traversa continued, “Throughout my more than twenty-five year career in the life sciences sector, I have had the pleasure of actively participating in several drug development programs and commercial launches, including Prozac®, Zyprexa® and Cymbalta®, among others. Relmada’s Board of Directors and management team include individuals with similarly strong records and areas of expertise that I strongly believe will enable us to successfully execute Relmada’s business priorities, including the continued development of BuTab. Indeed, Relmada’s business is at an inflection point with significant value creation opportunities possible within our portfolio over the next 12 to 24 months. We are excited by these opportunities and look forward to continuing to develop these treatments to benefit patients and drive long-term stockholder value.”
“I am very excited by the opportunity to work on the development of such a promising program,” said Richard Mangano, CSO of Relmada Therapeutics. “This data clearly indicates for the first time a promising outlook for the successful pathway to a NDA filing for a orally available buprenorphine.”
The clinical study conducted by INC Research, a leading global contract research organization (CRO), was designed to assess the safety, tolerability, and pharmacokinetics of BuTab in approximately 30 healthy volunteers. The key objective of the study was to assess if buprenorphine can be delivered orally and reach safe and effective blood levels through the gastrointestinal route of administration, which was achieved based on the topline analysis.
Conference Call and Webcast
Members of Relmada’s senior management team will hold a conference call on Thursday, December 10, 2015 at 8:30 a.m. ET. Also participating in the conference call is one of Relmada’s scientific advisors, Gavril Pasternak, M.D., Ph.D., Anne Burnett Tandy Chair in Neurology at Memorial Sloan-Kettering Cancer Center and laboratory head in the Molecular Pharmacology and Chemistry Program within the Sloan-Kettering Institute. Dr. Pasternak’s research focuses on opioid receptors and their mechanisms of action. He has demonstrated the importance of different sets of mu receptor subtypes in the actions of various opioid analgesics and identified a set of subtypes that offer a unique target for the development of analgesics lacking opioid side-effects.
The dial-in numbers are (877) 869-3847 for domestic callers and 201-689-8261 for international callers. A live webcast of the conference call and replay will be available online from the investor relations page of the Company’s corporate website at www.relmada.com.
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.
SOURCE: Relmada Therapeutics
Post Views: 139
NEW YORK, NY, USA I December 9, 2015 I Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced topline results of a proof-of-concept pharmacokinetic study in healthy volunteers using its BuTab (REL-1028), an investigational, oral formulation of buprenorphine, an opioid that is broadly used to treat both addiction and chronic pain. BuTab is designed to be delivered orally and reach safe and effective blood levels of buprenorphine through the gastrointestinal route of administration due to its modified release profile. There are currently no commercially available oral formulations of buprenorphine that result in gastrointestinal absorption.
“We are very pleased with this BuTab trial results as we have demonstrated for the first time that buprenorphine can be delivered at therapeutic level through the gastrointestinal route,” said Sergio Traversa, CEO of Relmada Therapeutics. “This opens the way for the successful development of a first in class orally delivered buprenorphine product, eagerly awaited in the market place.”
Dr. Traversa continued, “Throughout my more than twenty-five year career in the life sciences sector, I have had the pleasure of actively participating in several drug development programs and commercial launches, including Prozac®, Zyprexa® and Cymbalta®, among others. Relmada’s Board of Directors and management team include individuals with similarly strong records and areas of expertise that I strongly believe will enable us to successfully execute Relmada’s business priorities, including the continued development of BuTab. Indeed, Relmada’s business is at an inflection point with significant value creation opportunities possible within our portfolio over the next 12 to 24 months. We are excited by these opportunities and look forward to continuing to develop these treatments to benefit patients and drive long-term stockholder value.”
“I am very excited by the opportunity to work on the development of such a promising program,” said Richard Mangano, CSO of Relmada Therapeutics. “This data clearly indicates for the first time a promising outlook for the successful pathway to a NDA filing for a orally available buprenorphine.”
The clinical study conducted by INC Research, a leading global contract research organization (CRO), was designed to assess the safety, tolerability, and pharmacokinetics of BuTab in approximately 30 healthy volunteers. The key objective of the study was to assess if buprenorphine can be delivered orally and reach safe and effective blood levels through the gastrointestinal route of administration, which was achieved based on the topline analysis.
Conference Call and Webcast
Members of Relmada’s senior management team will hold a conference call on Thursday, December 10, 2015 at 8:30 a.m. ET. Also participating in the conference call is one of Relmada’s scientific advisors, Gavril Pasternak, M.D., Ph.D., Anne Burnett Tandy Chair in Neurology at Memorial Sloan-Kettering Cancer Center and laboratory head in the Molecular Pharmacology and Chemistry Program within the Sloan-Kettering Institute. Dr. Pasternak’s research focuses on opioid receptors and their mechanisms of action. He has demonstrated the importance of different sets of mu receptor subtypes in the actions of various opioid analgesics and identified a set of subtypes that offer a unique target for the development of analgesics lacking opioid side-effects.
The dial-in numbers are (877) 869-3847 for domestic callers and 201-689-8261 for international callers. A live webcast of the conference call and replay will be available online from the investor relations page of the Company’s corporate website at www.relmada.com.
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.
SOURCE: Relmada Therapeutics
Post Views: 139
