BDSI discontinues plan for further development resulting in an anticipated $16 million in operating plan savings in 2017 that extends cash runway R&D efforts to focus on buprenorphine 30-day injection for opioid dependence and pain which complement BDSI's existing marketed products, BELBUCA® and BUNAVAIL® RALEIGH, N. 13, 2016 /PRNewswire/ -- Bio Delivery Sciences International, Inc. (NASDAQ: BDSI) announced that its Phase 2b clinical study assessing the efficacy and safety of Clonidine Topical Gel for the management of painful diabetic neuropathy failed to show a statistically significant difference in pain relief between Clonidine Topical Gel and placebo. As a result, BDSI is discontinuing further development of the product at this time. "We can comfortably say that the changes made to the protocol design provided us with a reliable and unambiguous data set that demonstrated that Clonidine Topical Gel, at this strength and in this delivery form, is not effective for the treatment of painful diabetic neuropathy. "We clearly indicated when we embarked on this study that following the changes we made to the protocol based on previous work, that the results would support a definitive decision," said Dr. As such, we have no further plans for development at this time, and the $16 million that was to be directed to this program for 2017 will now allow us to extend our cash runway into fourth quarter of next year." Dr. Sirgo continued, "We will focus our R&D efforts on two important and exciting programs for our buprenorphine 30-day injection product in development - opioid dependence and chronic pain. Both are areas complimentary to BELBUCA and BUNAVAIL, where buprenorphine efficacy has previously been established with other products, and BDSI has considerable clinical expertise and regulatory experience with FDA." About Bio Delivery Sciences International Bio Delivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. tamoxifen endometrial cancer An aqueous gel in unit dose form and suitable for topical delivery of clonidine and comprising clonidine, a water-gelling amount of a pharmaceutically acceptable gelling agent and having a p H value in the range of about 6 to about 8.5. Clonidine is present in an amount in the range of about 0.05 to about 3.5 milligrams per unit dose and at a concentration in the range of about 0.01 to about 0.5 weight percent. Sympathetically maintained peripheral neuropathic pain syndromes of acute or chronic origin can encompass painful diabetic neuropathy (PDN), post-herpetic neuralgia (PHN), complex regional pain syndrome(CRPS) and like chronic non-malignant neuropathic pain syndromes. Patients with sympathetically maintained peripheral neuropathic pain syndromes typically have stimulus-independent (ongoing) pain and stimulus-dependent pain (hyperalgesia). Conventional treatments for these pain syndromes include oral administration of tricyclic antidepressants, anti-epileptics, and other miscellaneous neurological agents. This drug stimulates α-adrenoceptors in the vasomotor centers, causing a reduction of sympathetic outflow from the central nervous system. Some prior attempts also have been made to treat sympathetically maintained peripheral neuropathic pain syndromes with adrenergic compounds such as clonidine or phentolamine. Both cardiac output and peripheral resistance are reduced resulting in a decrease in blood pressure. Clonidine, in particular, is a potent α-adrenergic partial agonist used primarily for the treatment of hypertension (Jarrott et al., “Clonidine: Understanding its disposition, sites, and mechanism of action”, Clin. Higher concentrations cause a vasoconstriction by activation of postsynaptic receptors in vascular smooth muscle. Metformin doses available Most topical medications are supplied as a cream, gel, or ointment. of 0.1% topical clonidine gel for diabetic peripheral neuropathy suggests topical clonidine. duloxetine dose for depression Patients treated with clonidine experienced decreased foot pain compared to the placebo group. In those who felt any level of pain to capsaicin, clonidine proved superior to the placebo treatment. Researchers concluded that topical clonidine gel significantly reduces the level of foot pain resulting from diabetic neuropathy. Oct 11, 2016. Topical application of 5% lidocaine gel without occlusion relieves. gabapentin 6%; amitriptyline 4%; bupivacaine 2%; and clonidine 0.2%. Research demonstrates that the topical gel clonidine decreases foot pain for diabetic patients suffering from neuropathy. Diabetic neuropathy is nerve damage that results from high blood sugar levels, most often striking the legs and feet. According to the National Institutes of Health, around half of all people with will develop nerve damage. However, symptoms often do not arise until 10 to 20 years after diabetes has been diagnosed. Depending on the affected nerves, symptoms of diabetic neuropathy can range from pain and numbness in the extremities to problems with the digestive system, urinary tract, blood vessels and heart. At Johns Hopkins University, researchers conducted a randomized, double-blind control study on clonidine as a topical treatment for diabetic neuropathic pain. To determine the patients' sensitivity to pain, researchers first applied 0.1 percent capsaicin (generates a heat sensation on skin) to an area on the patients' legs for 30 minutes. Clonidine decreases blood tension by minimizing the degrees of certain chemicals in your blood. This allows your blood vessels to unwind and also your heart to defeat much more slowly as well as quickly. Clonidine is used to deal with high blood pressure (hypertension). The Kapvay brand name of clonidine is utilized to deal with attention deficiency hyperactivity ailment (ADHD). Just before you take clonidine, inform your medical professional if you have heart problem or extreme coronary artery condition, a heart rhythm problem, slow-moving heartbeats, low blood tension, a record of cardiovascular disease or stroke, renal illness, or if you have actually ever before had a sensitive reaction to a clonidine transdermal skin patch (Catapres TTS). Tell the cosmetic surgeon ahead of time that you are using clonidine if you require surgical procedure. You might should stop using the medication for a brief time. Clonidine topical gel US6534048B1 - Topical clonidine preparation - Google Patents, Topical Treatment Could Ease Neuropathy Pain - Diabetic Connect Cytotec images SpeedGel Rx® is a prescription homeopathic topical analgesic gel that provides relief of. Duraclon® Analgesic Clonidine HCl, Preservative Free 100 mcg / mL. Gensco Laboratories 35781021002 - McKesson Medical-Surgical Transdermal Pain Management Formulations – Pharmacy Solutions. BioDelivery Sciences Announces Clonidine Topical Gel for. A phase 2b double-blind, randomized, placebo-controlled clinical trial, showed that a topical clonidine 0.1% gel relieved pain in adults with painful diabetic. prednisolone 4mg Comprehensive clonidine topical gel arc-4558, clonidine portfolio, including molecular targets, MOA, partnerships, milestones. Pipeline & competitive intelligence. Clinical & deal history. Market drivers & investment opportunities. However, the development of a new generation of transdermal gels has changed this. These new. Clonidine's topical effects were discovered when some.