NIH awards $4 million research grant to AllTranz

AllTranz, Inc., a specialty pharmaceutical company focused on developing drugs to treat a variety of neurologic and inflammatory disorders, today announced that it has been awarded a $4 million research grant from the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), to advance the company’s transdermal tetrahydrocannabinol (THC) patch for the treatment of marijuana dependence and withdrawal. The grant was awarded through the American Recovery and Reinvestment Act of 2009 (ARRA) and will directly support preclinical development and a planned Phase I clinical study.

“We are pleased to receive this grant from NIDA and are proud that peer review has recognized the potential of our innovative approach to help people addicted to marijuana overcome their drug dependence and withdrawal symptoms,” said Dr. Audra Stinchomb, Chief Scientific Officer of AllTranz Inc. “By delivering low, steady levels of THC using our transdermal patch, patients don’t experience the euphoria associated with higher levels.”

“NIDA is interested in exploring the role of transdermal THC delivery as an innovative way to treat marijuana withdrawal symptoms and dependence,” said Dr. Nora Volkow, NIDA’s director. “This is especially relevant to our efforts to fill a critical gap in available treatments for the many Americans struggling with marijuana-related disorders and their detrimental medical and social consequences.”

AllTranz’s patented system presents significant advancements in transdermal drug delivery. The novel drug delivery technology allows for the non-invasive, non-oral, controlled delivery of THC. The non-plant based THC patch is designed to decrease the chance of side effects including drowsiness, dizziness, and the “high” feeling, as compared to ingesting a capsule, using a spray inhaler, or smoking marijuana. The patch will reduce dosing frequency and is expected to improve marijuana withdrawal and addiction symptoms, similar to nicotine patch treatment for tobacco smoking cessation.

The patch is initially being developed for marijuana withdrawal and dependence. Additionally, because of THC’s wide-ranging therapeutic and clinical benefits, AllTranz is proceeding with development of the patch for other indications, including cancer chemotherapy nausea and vomiting, AIDS patient appetite stimulation, and multiple sclerosis (MS) pain. Separate Phase II clinical trials would be pursued for each indication.

Following completion of preclinical studies, AllTranz expects to submit an Investigational New Drug (IND) application and initiate a Phase I clinical trial to examine the safety of the patch, which will be conducted through the Lifetree Clinical Research Center for Neuroscience Research, which is recognized as a therapeutic leader in central nervous system (CNS) and analgesia research.