Teva (NYSE:TEVA) said last week that it launched a generic version of Pfizer‘s (NYSE:PFE) Flector diclofenac epolamine patch. Using a nonsteroidal anti-inflammatory drug, the topical patch is designed to treat acute pain due to minor strains, sprains and contusions. Pfizer’s Flector patch garnered annual sales of $123 million in the U.S. as of Dec. 2018, according […]
Pain Management
Former PixarBio worker pleads guilty in fraud case
A former PixarBio (OTC:PXRB) employee pleaded guilty last Friday to charges of fraud and obstruction, according to a recent report from the Boston Business Journal. The employee, Jay Herod, was accused of making false statements to the SEC and impeding their investigation, as well as manipulating company stock trades and misleading investors, according to the report. […]
FDA takes big step toward over-the-counter naloxone
In a first for the agency, the FDA has developed and tested a consumer-friendly Drug Facts label to support the development of an over-the-counter version of naloxone, an emergency opioid overdose treatment. A DFL is required for OTC drug products and the FDA has never before proactively developed and tested one. But in this case, […]
Medtronic kicks off study for pain pump
Medtronic (NYSE:MDT) said today that it enrolled the first patient in a study to assess the use of its SynchroMed II intrathecal drug delivery system as an alternative to oral opioids. The 100-patient Embrace TDD study is slated to follow patients who have weaned off all oral opioids, in the hopes of positioning the SynchroMed II […]
Pear Therapeutics closes $64m Series C round
Pear Therapeutics said this month that it closed a $64 million Series C round led by Temasek. The Boston-based company plans to use its newly-acquired funds to support the global commercialization of its reSET prescription digital therapeutics and fund its clinical pipeline, as well as buy up additional assets. Other investors in the round include […]
Sandoz, Pear launch digital therapy for opioid use disorder
Novartis (NYSE:NVS) division Sandoz and Pear Therapeutics this week kicked off the U.S. commercial launch of the first FDA-cleared prescription digital therapy for people with opioid use disorder. The companies partnered to commercialize a 12-week cognitive behavioral therapy intended to be used in tandem with outpatient treatment. The therapy includes transmucosal buprenorphine and contingency management designed to reinforce […]
Heron Therapeutics wins priority review for postoperative pain drug
Shares in Heron Therapeutics (NSDQ:HRTX) rose today after the biotech reported that the FDA gave priority review status to its investigational postoperative pain drug. The company’s HTX-011 product is a long-acting formulation of bupivacaine in combination with the anti-inflammatory meloxicam. Heron touts the product as the first dual-action, fixed-combination drug designed to address postoperative pain […]
Ocular Therapeutix wins FDA nod for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza. The company’s device is designed […]
FDA warns on pain drugs for implantable pumps
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. […]
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 […]