Alliance Pharma (LON:APH) has acquired the rights to Smith & Nephew‘s (NYSE:SNN) anesthetic gel Ametop for $7.5 million, according to the specialty pharmaceutical company. The product, which Smith & Nephew has been selling in the U.K., Ireland, New Zealand and Canada for at least 10 years, is designed to numb a patient’s skin before an injection. […]
Pain Management
Flexion CEO: Setting Zilretta up to succeed with a history lesson
Locally acting therapies are like a religion to Flexion Therapeutics (NSDQ:FLXN) co-founder & CEO Dr. Mike Clayman, who spent decades at Eli Lilly (NYSE:LLY) with the company’s co-founder, Dr. Neil Bodick, watching promising compounds fail in late-stage trials on the heels of unanticipated safety results. “That’s part of the reason, not the whole reason but part of […]
FDA approves first once-monthly buprenorphine injection to treat opioid addiction
Indivior (LON:INDV) shares jumped today after the FDA approved its once-monthly buprenorphine injection for the treatment of opioid addiction in adult patients who have started therapy with a transmucosal buprenorphine product. The company’s once-monthly injection is the first medication-assisted treatment option of its kind, the regulatory agency touted. Before Indivior’s Sublocade was approved, all other available […]
Egalet’s extended-release, abuse-deterrent opioid succeeds in Ph3 trial
Shares in Egalet Corp. (NSDQ:EGLT) soared this morning in pre-market activity after the company reported that its abuse-deterrent, extended-release oxycodone candidate met the primary endpoint of a Phase III pain relief trial. The Wayne, Penn.-based company compared the efficacy and safety of its product to a placebo in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic […]
FDA wants to improve access to generic abuse-deterrent opioids: here’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in […]
Using digital pills, researchers find patients consume fewer opioids than expected
Clinicians at Brigham and Women’s Hospital published a paper in the December issue of Anesthesia & Analgesia showing that digital pills successfully monitored patients taking opioids following an injury. To track the participants’ opioid use, researchers used etectRx‘s ID-Cap system, which includes a capsule embedded with an ingestible sensor. “As an investigational tool, the digital pill provides a […]
After FDA nod, Flexion launches osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) today launched its Zilretta therapy designed to help patients manage pain associated with osteoarthritis of the knee. The Burlington, Mass.-based company’s extended-release intra-articular injection combines a commonly administered, short-acting corticosteroid with a polylactic-co-glycolic acid matrix using Flexion’s microsphere technology. The FDA approved Zilretta last month after granting it fast track status in 2015. […]
iVeena finishes pilot trial of sustained-release implant
iVeena Delivery Systems said earlier this month that it finished a pilot trial for its IVMED-10 bioerodible implant designed to treat pain and inflammation after cataract surgery. Placed during cataract surgery, the sustained-release implant delivers dexamethasone for two weeks from the lens capsule. The company’s Phase I/IIa trial enrolled eight patients and found that IVMED-10 […]
Scilex seeks EU nod for ZTlido lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that it filed a marketing authorization application seeking approval for its ZTlido lidocaine patch. The San Diego, Calif.-based company said it is pursuing a hybrid regulatory pathway with the Medicines and Healthcare Products Regulatory Agency in the U.K., which will serve as the lead review agency. The company also plans […]
Q Biomed looks to dust off shelved cancer pain drug
Denis Corin has spent the last 13 years in the biopharmaceutical industry watching and learning from scientists and companies that fail. “I’ve seen so many promising and innovative young technologies really struggle along or die on the vine because they’re run by scientists who don’t really understanding capital raising,” he told Drug Delivery Business News. “They run […]
