A novel version of a proven drug product, MepiGel (REL-1021), is a proprietary topical dosage form of the local anesthetic mepivacaine for the treatment of painful peripheral neuropathies, such as painful diabetic neuropathy, postherpetic neuralgia and painful HIV-associated neuropathy. Mepivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to the brain. It is chemically related to bupivacaine but pharmacologically related to lidocaine. Mepivacaine is currently indicated for infiltration, nerve block and epidural anesthesia. Relmada has received two FDA Orphan Drug Designations for mepivacaine, one each for "the treatment of painful HIV-associated neuropathy" and for "the management of postherpetic neuralgia," or PHN. We have selected the formulations to be advanced into clinical studies for MepiGel after the evaluation of results from in vitro and ex vivo studies comparing various topical prototypes of mepivacaine.
REL-1021 (MepiGel) has completed toxicology studies.
- Received two FDA orphan drug designations
- For the management of postherpetic neuralgia (PHN)
- For the treatment of painful HIV-associated neuropathy
- 7-year market exclusivity upon FDA approval for each indication
- The gel can be used alone or in combination with oral pain therapies such as Lyrica® and Cymbalta® providing significant market potential
- The gel form provides a number of advantages over existing patch forms of treatment
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.
By the Numbers
U.S. individuals suffering from neuropathic pain
U.S. individuals who say that their neuropathic pain is under control
Advantages over patches
- Potential for greater skin penetration
- Potential for greater skin retention
Avoids adhesion problems
- Eliminates hassle of the patches and practical issues related to applying/adhering to hands, feet and skin with hair