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 […]
Pain Management
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. “The clinical data from our Phase III study also showed […]
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 […]
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. Braeburn’s […]
Milestone Scientific wins 510(k) clearance for epidural anesthesia system
Milestone Scientific (NYSE:MLSS) said today that its CompuFlo epidural computer-controlled anesthesia system won 510(k) clearance from the FDA. The Livingston, N.J.-based company’s CompuFlo Epidural instrument uses dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and significantly reduce complications in real-time, according to Milestone. Shares in the company jumped up 18% today, trading […]
FDA asks Endo to pull Opana from the market over concerns of abuse
The FDA asked Endo Pharmaceuticals (NSDQ:ENDP) to pull its opioid pain med, Opana ER, from the market, saying that the benefits of the abuse-deterrent drug no longer outweigh the risks. The move marks the 1st time the federal regulatory watchdog has urged a company to remove an opioid painkiller due to concerns of abuse. “We are facing […]
Critics allege misleading campaigns, poorly-cited data fueled opioid addiction crisis
The state of Ohio filed a lawsuit against opioid-makers this week, alleging that the companies produced misleading marketing schemes to convince doctors and patients that opioids were not addictive. Ohio isn’t alone – Mississippi and West Virginia have filed similar cases against major players in the pharmaceutical industry. Purdue Pharma, Johnson & Johnson (NYSE:JNJ), Endo […]
Mallinckrodt faces probe over price hikes for injectable pain-killer
Sen. Claire McCaskill (D-Mo.) penned a letter to Mallinckrodt Pharmaceuticals (NYSE:MNK) last week, probing for details about the company’s pricing strategies for its injectable pain-killer, Ofirmev. Mallinckrodt acquired Ofirmev in 2014, when it bought Cadence Pharmaceuticals in a $1.4 billion deal. In May of that year, Mallinckrodt hiked the pain-killer’s list price from $14.75 per vial to […]