Author(s): Allen Loyd V Jr Issue: May/Jun 2016 - Volume 20, Number 3 View All Articles in Issue Abstract: A formulation for preparing Ketamine Hydrochloride 5%, Gabapentin 10%, Clonidine Hydrochloride 0.2%, and Baclofen 2% in Lipoderm. Includes ingredients, method of preparation, discussion, and references for the compounding pharmacist. No controlled, long-term, and/or prospective studies designed to assess the efficacy of systemic clonidine have yet been published. However, a new formulation of topical clonidine gel with minimal systemic activity was studied in an open-label, uncontrolled pilot study that decreased allodynia and hyperalgesia in some patients with CRPS. Gaurav Gupta, MD Assistant Professor, Section Head, Endovascular and Cerebrovascular Neurosurgery, Fellowship Director, Endovascular Neurosurgery Fellowship (Site), Department of Surgery, Division of Neurosurgery, Rutgers Robert Wood Johnson Medical School Gaurav Gupta, MD is a member of the following medical societies: American Academy of Neurology, American Association for the Advancement of Science, American Association of Neurological Surgeons, American College of Surgeons, American Heart Association, American Medical Association, Congress of Neurological Surgeons, Facial Pain Association, Society for Neuroscience, Society of Neuro Interventional Surgery Disclosure: Nothing to disclose. Francisco Talavera, Pharm D, Ph D Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference Disclosure: Received salary from Medscape for employment. Glenn Lopate, MD Associate Professor, Department of Neurology, Division of Neuromuscular Diseases, Washington University in St Louis School of Medicine; Consulting Staff, Department of Neurology, Barnes-Jewish Hospital Glenn Lopate, MD is a member of the following medical societies: American Academy of Neurology, American Association of Neuromuscular and Electrodiagnostic Medicine, Phi Beta Kappa Disclosure: Serve(d) as a director, officer, partner, employee, advisor, consultant or trustee for: Alnylam Pharmaceuticals Received income in an amount equal to or greater than $250 from: Alnylam Pharmaceuticals; GLG. Stephen A Berman, MD, Ph D, MBA Professor of Neurology, University of Central Florida College of Medicine Stephen A Berman, MD, Ph D, MBA is a member of the following medical societies: Alpha Omega Alpha, American Academy of Neurology, Phi Beta Kappa Disclosure: Nothing to disclose. Jorge E Mendizabal, MD Consulting Staff, Corpus Christi Neurology Jorge E Mendizabal, MD is a member of the following medical societies: American Academy of Neurology, National Stroke Association, American Headache Society, Stroke Council of the American Heart Association Disclosure: Nothing to disclose. Anthony H Wheeler, MD Department of Neurology, Bethany Medical Center Anthony H Wheeler, MD is a member of the following medical societies: American Academy of Neurology, American Academy of Pain Medicine, North American Spine Society, North Carolina Medical Society Disclosure: Received salary from Allergan, Inc.
Bio Delivery Sciences International (BDSI) has entered into a worldwide licensing agreement with privately held Arcion Therapeutics, where BDSI will develop and commercialize topical clonidine gel (formerly ARC4558) for the treatment of painful diabetic neuropathy (PDN) and potentially other indications. BDSI will make an upfront payment of $2 million to Arcion in the form of unregistered shares of BDSI common stock. Additional financial terms include a milestone payment to Arcion of $2.5 million in unregistered shares of BDSI stock upon acceptance by the FDA of a New Drug Application (NDA) for topical clonidine gel and a cash payment to Arcion of between $17.5 and $35 million upon NDA approval, depending on certain regulatory and commercial considerations. In addition, the licensing agreement includes sales milestones and low single-digit royalties on net worldwide sales. “Though we remain focused on preparing our Bunavail NDA for filing in the coming months and completing our BEMA Buprenorphine chronic pain phase III trials, this product acquisition allows us to build our pipeline, while applying our expertise in pain product development, utilizing the FDA’s 505(b)(2) regulatory process, and diversifying outside of opioid therapy and our BEMA technology.” Evidence has shown that clonidine stimulates an inhibitory receptor in the skin associated with pain fibers. “We are excited about this late stage product where efficacy has already been demonstrated in a very painful condition with a significant unmet need,” said Dr. Arcion has developed a patented topical gel formulation of clonidine and has assessed its effectiveness in reducing pain in PDN in a double-blind, placebo-controlled, phase II study where the primary study endpoint was the change in pain intensity over a three month treatment period in diabetic foot pain. A significant treatment difference was seen in the planned subset analysis of diabetic patients who had documented evidence of “functioning pain receptors” in the skin of the lower leg (p=0.01, n=63) thus, at a minimum, supporting the effectiveness of topical clonidine in diabetic patients with functioning pain receptors of the skin. In the overall population that included patients without “functioning nerve receptors,” there was a trend favoring topical clonidine gel (p=0.07, n= 182), though the overall results did not reach statistical significance. The process of creating an animated video is complicated and the steps from start to finish numerous. Video is a wonderful marketing tool that easily engages people and rapidly improves lead generation and sales. In order to create a video that will be successful, knowing these steps will help you. It will empower you to understand what to look for, what to expect, and what to watch out for. So getting clear on what you want your audience to understand about your story is essential. A good place to start is to ask yourself this question; what do I want my video to convey to my customer? Others focus exclusively on 3D work for industrial applications or commercials. Consider answering these questions before you pick your vendor, it will help you to decide what kind of project you want to build: Animation studios and companies that can provide animation services are numerous around the world. Others are a blend of video studios who do visual effects and motion design. Because of this, it’s important to hunt around and do your research on the kind of company you’d like to work with. If you know you want a 2d explainer video at a lower cost, there are many options out there of companies that exclusively produce those products.
The effect of clonidine gel and capsaicin cream in relieving pain associated with. study showed the comparable efficacy of clonidine gel in comparison with. Sep 12, 2014. 2. Gilron I, Watson PN, Cahill CM, Moulin DE. Neuropathic Pain A Practical Guide for the Clinician. CMAJ 2006; 1753; 265-2. Clonidine gel.