Relmada Therapeutics Inc., a clinical-stage company developing novel therapies for the treatment of chronic pain, today announced a positive outcome of its pivotal pharmacokinetic study for LevoCap ER. Based on the positive outcome of this study, Relmada is now preparing the Phase III development program and is planning to submit a request with the FDA to discuss the final pathway to the New Drug Application (NDA) for this product during the fourth quarter of this year.
The study, REL-1015-023, designed to define the pharmacokinetic profile of levorphanol ER compared to the immediate release formulation (IR), was an open-label randomized, crossover study of the oral bioavailability of three different doses of extended release (ER), abuse resistant levorphanol under fasted and fed conditions vs. immediate release (IR) levorphanol under fasted conditions when administered to healthy adult volunteers. The results for the 26 subjects that completed the study showed good bioavailability for the ER formulations with dose proportionality and a profile that is suitable for a once a day administration. No serious events or unexpected side effects were experienced during the study.
"We are pleased with the outcome of this study and believe that we now have enough solid information to discuss with the FDA the plan for the next and final stage of development for this important product," said Sergio Traversa, Chief Executive Officer of Relmada.
LevoCap ER, is Relmada's lead product and is intended to add a powerful new tool to treat pain where opioids alone or non-opioids alone do not provide adequate relief. Unlike other opioids, levorphanol, the active ingredient in LevoCap ER modulates pain through both opioid pathways and noradrenergic pathways thereby providing pain relief through multiple mechanisms in one capsule. Levorphanol has also been shown to partially reverse analgesic tolerance to morphine and may therefore benefit patients who are tolerant to the analgesic effects of their current opioid. Based on its pharmacological profile, LevoCap alone should demonstrate improved efficacy in a broader patient population compared to other opioids. This includes the vast category of patients affected by chronic pain with combined nociceptive and neuropathic components, which frequently require treatment with two or more pain medications to achieve efficacy.
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