Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its SureTune3 deep-brain stimulation software, which is designed to map lead locations and indicate the level of stimulation. The Fridley, Minn.-based Medtronic said its DBS devices are approved in the E.U. for treating Parkinson’s disease, dystonia, essential tremor, obsessive-compulsive disorder and […]
Neuromodulation/Neurostimulation
Semnur touts Phase I/II trial of non-opioid pain-killer
Semnur Pharmaceuticals touted data today from a Phase I/II pharmacokinetic trial of its injectable, non-opioid pain-killer, SP-102. The trial enrolled 12 patients with radicular pain. The trial met its primary endpoint and showed that single epidural injection of SP-102 could provide a sustained analgesic effect for 1 month. Get the full story at our sister […]
Camarus, Braeburn tout Phase II data for long-acting buprenorphine depot
Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals touted data yesterday from a Phase II trial of its long-acting buprenorphine depot. The 47-patient trial found that CAM2038 blocks the effects of opioids and suppresses withdrawal symptoms in adults with opioid use disorder. The in-patient trial included 5 3-day test sessions to evaluate the patients’ response to randomized […]
BioDelivery wins Health Canada approval for Belbuca pain relief product
BioDelivery Sciences International (NSDQ:BDSI) said today that Health Canada approved its buprenorphine hydrochloride buccal film, Belbuca, for the management of pain severe enough to necessitate daily, long-term opioid treatment and for which alternative management options are inadequate. The company said it plans to commercialize Belbuca in Canada through an unnamed partner and that the launch […]
Indivior touts late-stage trial for monthly buprenorphine depot
Indivior (LON:INDV) touted data today from its pivotal Phase III trial for RBP-6000, a once-monthly injectable buprenorphine depot for the treatment of adults with opioid use disorder. The 24-week study met its primary and key secondary endpoints for both dosage regimens, according to the company. Get the full story at our sister site, Drug Delivery […]
LivaNova wins expanded MR indication for VNS Therapy device
LivaNova (NSDQ:LIVN) said today it won FDA approval for expanded MRI labeling for its Vagus Nerve Stimulation Therapy device, touting it as the only epilepsy device cleared by the FDA for MRI scans. With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to […]
BioDelivery Sciences brings novel drug delivery tech to pain management, opioid addiction
As the American public grapples with an ongoing opioid crisis, pain management companies are looking for ways to innovate their products in an attempt to avoid potential abuse. For years, BioDelivery Sciences International (NSDQ:BDSI) has developed mucoadhesive buccal films loaded with painkillers for pain management and addiction therapy. Now it is developing a buprenorphine depot […]
Scilex touts head-to-head study of lidocaine pain-relief patch
Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals touted data today from a head-to-head clinical adhesion study of its ZTlido lidocaine patch, comparing it to the EU reference product, Versatis. ZTlido is a lidocaine patch in development for the treatment of post-herpetic neuralgia – a severe neuropathic pain condition that affects elderly people and patients who have […]
Mallinckrodt responds to probe into pricey injection pain-killer
Mallinckrodt Pharmaceuticals (NYSE:MNK) issued a response today to Sen. Claire McCaskill (D-Mo.) and her probe into the company’s pricing strategies for its injectable pain-killer, Ofirmev. McCaskill wrote to the company at the end of May, suggesting that that the company’s price increases could have cost hospitals millions and may have pushed healthcare practitioners to use cheaper painkillers, including highly […]
Adapt Pharma touts usability data for Narcan nasal spray
Adapt Pharma touted data today from 2 human factors studies that evaluated the usability of its Narcan nasal spray by adolescents and people with low literacy. The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in a nasal spray to someone experiencing an opioid overdose and does not require […]
Braeburn, Knight seek Health Canada nod for opioid dependence implant
Braeburn Pharmaceuticals and Knight Therapeutics (TSE:GUD) said today that Health Canada has agreed to review Knight’s new drug submission for Probuphine, a buprenorphine subdermal implant designed to treat opioid drug dependence. In February last year, Braeburn and Knight inked an exclusive distribution and sublicense deal, giving Knight the exclusive right to distribute Probuphine in Canada. Get […]