Flexion Therapeutics (NSDQ:FLXN) said today that the FDA accepted its New Drug Application for Zilretta – its extended-release steroid injection. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection in 2015. Flexion touts Zilretta as the 1st intra-articular, extended-release therapy for patients with knee osteoarthritis pain. The injection uses microsophere technology […]
Pain Management
West Pharmaceutical Services introduces new drug delivery safety products
West Pharmaceutical Services, an injectable drug administration technology provider, has introduced two new products meant to improve drug delivery safety. The LyoSeal cap is all-plastic and provides instant sealing for lyophilized drug products. West designed the LyoSeal to minimize risks involved with established lyophilization processes while maintaining the necessary sealing requirements. The NovaGuard SA Pro […]
InSitu Biologics touts preclinical data for non-opiate hydrogel painkiller
InSitu Biologics touted preclinical data for its non-opiate, hydrogel-based painkiller, AnestaGel, for use in peri-operative regional pain management. The St. Paul, Minn.-based company designs therapies using its Matrix biohydrogel material. Independent tests compared operative site injections of AnestaGel and Pacira Pharmaceutical’s (NSDQ:PCRX) Exparel. According to InSitu, the data showed that AnestaGel lasted longer and provided a […]
Abbott touts study showing SCS helps curb opioid use in chronic pain patients
Abbott (NYSE:ABT) touted data from a 5,400 patient study evaluating daily opioid use following spinal cord stimulation therapy in patients with chronic pain. The researchers found that average daily opioid use declined or remained steady for patients with a spinal cord stimulation system compared to patient use of opioids prior to the implant. Patients who had the […]
Braeburn Pharmaceuticals files plans for $150m IPO
Braeburn Pharmaceuticals filed plans for a $150 million initial public offering last week with the Securities & Exchange Commission, leaving out any specific pricing details. The Princeton, N.J.-based company plans to list its shares on the Nasdaq market under the symbol “BBRX”. JPMorgan, Merrill Lynch and Deustche Bank are underwriters for the offering and Apple […]
Anika Therapeutics wins CE Mark for tennis elbow injection
Anika Therapeutics (NSDQ:ANIK) said today that it won CE Mark approval in the European Union for its Orthovisc-T injection. The Bedford, Mass.-based company’s treatment is indicated to relieve pain and restore function in tendons affected by tennis elbow, or chronic lateral epicondylosis. The sodium hyaluronate injection promotes tendon gliding and repair at the site of the […]
BioDelivery names Ginsberg as biz dev veep | Personnel Moves, Dec. 14, 2016
BioDelivery Sciences International (NSDQ:BDSI) said today that it named Peter Ginsberg as its VP of business development. Prior to joining the Raleigh, N.C.-based company, Ginsberg led business development at United Therapeutics and directed a $350 million sale of the company’s priority review voucher. He has also served as VP of business & technology development for […]
AcelRx seeks FDA nod for non-invasive sufentanil painkiller
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it submitted a new drug application to the FDA for its ARX-04 sublingual sufentanil tablet. The non-invasive compound has been studied as a treatment for patients experiencing moderate or severe acute pain and is administered in a medically supervised setting using a disposable, pre-filled, single-dose applicator. The Redwood City, Calif.-based […]
BioDelivery’s topical gel for diabetic neuropathy fails in phase IIb trial
BioDelivery Sciences International (NSDQ:BDSI) said today that its clonidine topical gel for pain relief in patients with diabetic neuropathy failed in a phase IIb clinical trial. Raleigh, N.C.-based BioDelivery will halt any further development of the painkiller. In the phase IIb clinical trial, BioDelivery’s topical gel did not demonstrate a statistically significant difference in pain relief […]
Flexion seeks FDA nod for osteoarthritis steroid injection
Flexion Therapeutics (NSDQ:FLXN) said today that it submitted a new drug application to the FDA for its extended-release steroid injection Zilretta. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection last year. The new drug application is based on data from a pivotal phase III clinical trial evaluating Zilretta in […]
