clonidine (ARC 4558) / Arcion, Collegium Pharma - LARVOL DELTA

Assessing the efficacy of topical formulations in diabetic neuropathy: a narrative review. (PubMed, J Diabetes Metab Disord) - "Potential options include 8% Capsaicin patch, 5% Lidocaine patch, Clonidine gel, Topical gabapentin, and an amitriptyline and ketamine combination. A promising area of research that requires further study is the effect of a combination of topicals in alleviated DNP."

Journal • Review • Diabetic Neuropathy • Neuralgia • Pain

Identification of Catecholamine and Drug Target α2A-Adrenoceptor in Human Testis and Human Testicular Peritubular Cells. (PubMed, J Clin Med) - "Background: Clonidine has been used in clinical medicine, e.g., to treat high blood pressure and other conditions...The results of this HTPCs-focused study only show the tip of the iceberg. It is likely that catecholamines/catecholaminergic drugs have the potential to interfere with human testicular functions."

Journal • Cardiovascular • Hypertension • Inflammation • IL6

Topical capsaicin for the management of painful diabetic neuropathy: a narrative systematic review. (PubMed, Pain Manag) - " About 8% Capsaicin patches were found to significantly reduce symptoms of diabetic peripheral neuropathy...Capsaicin cream did not have superior improvement of pain as compared with clonidine gel (p = 0.931)... Topical capsaicin treatments are a potentially beneficial peripherally acting medication. Further research is needed to determine the best means of ameliorating the side effects of treatments."

Journal • Review • Dermatology • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Topical clonidine for neuropathic pain in adults. (PubMed, Cochrane Database Syst Rev) - "This is an update of a review published in 2015, for which our conclusions remain unchanged. Topical clonidine may provide some benefit to adults with painful diabetic neuropathy; however, the evidence is very uncertain. Additional trials are needed to assess TC in other neuropathic pain conditions and to determine whether it is possible to predict who or which groups of people will benefit from TC."

Journal • Review • Diabetic Neuropathy • Hypertension • Neuralgia • Pain

A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: University of Texas Southwestern Medical Center

New P3 trial • Biosimilar • Renal Cell Carcinoma

BioDelivery Sciences provides corporate update and reports second quarter 2015 financial results (PRNewswire) - "Nearly 14,000 prescriptions dispensed for BUNAVAIL during second quarter 2015; 27% increase over first quarter. BUNAVAIL prescriber base expanded to 1,728 physicians, with 684 new prescribers added during the second quarter....BELBUCA (buprenorphine HCl) buccal film for treatment of chronic pain: PDUFA date of October 23rd. Clonidine Topical Gel for treatment of painful diabetic neuropathy...New study planned to commence in the fourth quarter of this year with a budget of $3-5 million."

Anticipated new trial • Anticipated PDUFA date • Commercial • Pain

Topical clonidine for neuropathic pain. (PubMed) - "Limited evidence from a small number of studies of moderate to low quality suggests that TC may provide some benefit in peripheral diabetic neuropathy. The drug may be useful in situations for which no better treatment options are available because of lack of efficacy, contraindications or adverse events. Additional trials are needed to assess TC in other neuropathic pain conditions and to determine how patients who have a chance to respond to the drug should be selected for treatment."

Review • Biosimilar • Diabetes • Pain

BioDelivery Sciences to present at the 6th Annual Credit Suisse Small & Mid Cap Conference and the Ladenburg Thalmann 2015 Healthcare Conference (PRNewswire) - "BioDelivery Sciences International...announced that the company will present at two upcoming healthcare conferences...BDSI will be discussing progress with the commercial launch of BUNAVAIL® (buprenorphine and naloxone buccal film), including the recently secured exclusive preferred formulary status with Tennessee Medicaid. Also discussed will be BELBUCA™ (Buprenorphine HCL buccal film)...The presentation will also provide an update on the status of Clonidine Topical Gel being studied for the treatment of painful diabetic neuropathy..."

Anticipated conference • Pain

BioDelivery Sciences provides business review and update in conjunction with filing of its 2013 annual report (PRNewswire) - "...anticipated third quarter 2014 launch of BUNAVAIL. Additionally, data from clinical studies of BUNAVAIL will be presented at the American Society of Addiction Medicine (ASAM) 45th Annual Medical-Scientific Conference, April 10-13, 2014 in Orlando, Florida. BEMA Buprenorphine for Chronic Pain. BDSI anticipates the second database lock from the Phase 3 trial for opioid experienced patients and subsequent $10 million milestone payment from Endo, to occur in mid-year 2014, and the potential filing of the NDA in late 2014 or early 2015. Clonidine Topical Gel for Painful Diabetic Neuropathy. A Phase 3 study will be initiated by the end of first quarter 2014 with the potential for interim data by year-end."

Anticipated clinical data • Anticipated financing • Anticipated launch US • Anticipated NDA • Anticipated new P3 trial • Pain

Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers (clinicaltrials.gov) - P1; N=60; Active, not recruiting; Sponsor: Boehringer Ingelheim; Recruiting -> Active, not recruiting

Enrollment closed • Acute Coronary Syndrome • Biosimilar • Chronic Kidney Disease • Heart Failure • Renal Cell Carcinoma

BioDelivery Sciences to present at the Rodman & Renshaw 18th Annual Global Investment Conference and the 7th Annual Credit Suisse Small and Mid Cap Conference (PRNewswire) - "Dr. Sirgo will discuss strategic initiatives supporting BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) and the launch of BELBUCA™ (buprenorphine) buccal film (CIII) by BDSI's commercial partner, Endo Pharmaceuticals. Also covered will be an update on the development of Clonidine Topical Gel for painful diabetic neuropathy and the buprenorphine 30-day injection for opioid dependence and chronic pain."

Anticipated conference • Anticipated pipeline update • Demo Pain • Pain

BioDelivery Sciences to present at the Stifel 2016 Healthcare Conference (PRNewswire) - "Dr. Sirgo will discuss strategic initiatives supporting BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) and the launch of BELBUCA® (buprenorphine) buccal film (CIII) by BDSI's commercial partner, Endo Pharmaceuticals. Also covered will be an update on the development of Clonidine Topical Gel for painful diabetic neuropathy and the buprenorphine 30-day injection for opioid dependence and chronic pain."

Anticipated pipeline update • Demo Pain • Pain

Adrenergic and cholinergic influence on the production of reactive oxygen species in human neutrophils (PubMed, Rev Peru Med Exp Salud Publica) - "The highest percentages of inhibition were shown at 10-2 M and 10-3 M. Salbutamol presented the maximum values with all the concentrations with a significant difference between its inhibition and that generated by the other drugs. Adrenergic and cholinergic stimuli have an inhibitory effect on the production of ROS in neutrophils of healthy individuals."

Journal

Induction of Non-Apoptotic Cell Death by Adrenergic Agonists in Human Oral Squamous Cell Carcinoma Cell Lines. (PubMed, Anticancer Res) - "Isoprenaline and dexmedetomidine induce non-apoptotic cell death by different mechanisms."

Journal • Preclinical

Topical treatments for diabetic neuropathic pain. (PubMed, Exp Ther Med) - "...In the present review, a summary is provided of the available agents for topical use in patients with DNP, including lidocaine plasters or patches, capsaicin cream, gel or patches, amitriptyline cream, clonidine gel, ketamine cream, extracts from medicinal plants including nutmeg extracts and Citrullus colocynthis extract oil, and certain compounded topical analgesics...Compounded topical agents are also effective and safe for patients with DNP and could be another area worthy of further investigation based on the strategy of using low-dose, complementary therapies for DNP. The findings indicate that developing topical drugs acting on different targets in the process of DNP is a valuable area of future research."

Journal • Review

A nonopioid approach to opioid discontinuation (Medscape) - "Today I'd like to speak about opioid discontinuation, and specifically the availability of a new treatment. I'd like to frame this by looking at the numerous clinical scenarios in which opioid discontinuation - that is, stopping opioid therapy - may be warranted. Lucemyra and other medicines that have been developed, perhaps not specifically for this, can be utilized, and perhaps should be proactively utilized to help accomplish the discontinuation of opioid therapy in those individuals for whom that is appropriate."

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