The FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps. Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said. […]
Pain Management
FDA to develop new framework for opioid analgesics following AcelRx approval
The FDA last week approved AcelRx‘s (NSDQ:ACRX) Dsuvia sufentanil product, noting that use of the opioid will be tightly restricted to adults experiencing acute pain in medically-supervised healthcare settings. Dsuvia is a tablet that is administered sublingually in a single-dose, pre-filled applicator. The company expects to launch its pain product in the first quarter of […]
Medtronic wins FDA nod for SynchroMedII myPTM drug therapy manager
Medtronic (NYSE:MDT) said today that the FDA approved its new SynchroMedII myPTM personal therapy manager intended for use in treating patients with chronic pain. The newly cleared device works with the company’s SynchroMedII intrathecal drug delivery system and is designed to handle delivering on-demand boluses within therapeutic limits set by physicians, the Fridley, Minn.-based company said. […]
Purdue acquires non-opioid painkiller with SpineThera purchase
Purdue Pharma announced today that it acquired SpineThera and a dexamethasone epidural product designed to treat low back pain. SpineThera’s SX600 therapy features tiny, biodegradable microspheres which enable sustained-release of dexamethasone. “We are pleased to partner with SpineThera to support further development of its novel steroid product for epidural injection for patients who suffer from […]
AcelRx shares fall as Sen. Markey calls on FDA to reject opioid painkiller
Shares in AcelRx (NSDQ:ACRX) fell last week after U.S. Sen. Ed Markey (D-Mass) called on the FDA to reject the drugmaker’s opioid painkiller, Dsuvia. The senator noted that the product, which is designed for use in medically-supervised settings, consists of sufentanil – an opioid that is up to 10 times as powerful as fentanyl. “Even in […]
Medtronic launches workflow system to help wean patients off oral opioids
Medtronic (NYSE:MDT) said today that it launched its Control Workflow system in the U.S. for use with its SynchroMed II intrathecal drug-delivery system. The medtech titan is hoping that, combined with its pain pump, the workflow system can help physicians in weaning patients off oral opioids. In a retrospective claims analysis, Medtronic found that 51% of […]
Teva wins FDA nod for sublingual film to treat opioid dependence
The FDA last week approved Teva Pharmaceuticals (NYSE:TEVA) Cassipa sublingual film as a maintenance treatment for opioid dependence. There are a number of brand name and generic versions of buprenorphine and naloxone therapies that are delivered via a sublingual film. Teva’s product contains 16 milligrams of buprenorphine and 4 milligrams of naloxone, bringing a new dosage […]
NeuroMetrix lands $4m milestone payment from GSK deal
NeuroMetrix (NSDQ:NURO) said this week that it reeled in a $3.8 million milestone payment from its collaboration with GlaxoSmithKline‘s (NYSE:GSK) consumer healthcare unit. The strategic deal between the two groups was first announced in January this year. According to the terms of the deal, GSK acquired exclusive ownership of NeuroMetrix’s Quell pain-relief device outside the U.S., […]
FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery. The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set […]
Anika shares plummet after Phase III trial misses endpoint
Shares in Anika Therapeutics (NSDQ:ANIK) fell more than -30% this week after the company reported that its osteoarthritis drug, Cingal, failed in a Phase III trial. The therapy, designed to treat osteoarthritis of the knee, is a combination of cross-linked hyaluronic acid and triamcinolone hexacetonide. The trial’s primary endpoint compared the pain reduction experienced by patients […]
