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AllTranz Awarded $4 Million Research Grant by NIH and NIDA
LEXINGTON, KY (Nov. 3, 2009) − AllTranz Inc., a specialty pharmaceutical company focused on developing drugs to treat a variety of neurologic and inflammatory disorders, 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.
About Marijuana Dependence
Marijuana is the most commonly used illicit drug in the United States. According to the 2008 National Survey on Drug Use and Health, more than 15 million Americans (nearly 5% of the U.S. population) aged 12 or older used marijuana at least once in the month prior to being surveyed. More than half of the individuals addicted to marijuana experience significant withdrawal symptoms if they try to quit. The withdrawal symptoms contribute to the relapse and maintenance of marijuana use. Withdrawal symptoms are similar to those experienced by people who quit cigarettes, cocaine and other drugs. Nearly two-thirds of marijuana users experience pronounced withdrawal symptoms that can include anxiety, irritability, depression, mood swings, and sleep problems.
Marijuana contains more than 400 chemicals, including many of the harmful substances found in tobacco smoke. Smoking one marijuana cigarette deposits about four times more tar into the lungs than a filtered tobacco cigarette and Harvard University researchers report the risk of a heart attack is five times higher than usual in the hour after smoking marijuana.
AllTranz Inc. is a privately held specialty pharmaceutical company focused on developing drugs to treat a variety of neurologic and inflammatory disorders. The company’s central technology leverages chemical prodrug delivery techniques developed by its founder and Chief Scientific Officer, Dr. Audra Stinchcomb. AllTranz has applied its technology in four key areas: prodrug development, abuse deterrence, unique microneedle formulations, and an internal drug development program. AllTranz’s strategy is to develop therapeutic products and form marketing collaborations with industry leaders in order to maximize their commercial potential. AllTranz’s proprietary technology can be applied to multiple clinical applications, including but not limited to cancer, AIDS, MS, marijuana withdrawal and neuropathic pain.