Stimwave Technologies spinout StimRelieve said today it enrolled the 1st patient in a clincal trial of its implantable StimRelieve device designed to treat chronic craniofacial nerve pain. The Ft. Lauderdale, Fla.-based company’s device is designed to be implanted near inflicted painful nerves to modulate nerve activity and provide therapeutic relief, the company said. The device is powered […]
Pain Management
FDA panel rules that benefits of Endo’s Opana opioid no longer outweigh risks
An FDA advisory panel ruled yesterday that the benefits of Endo Pharmaceutical‘s opioid painkiller, Opana ER, no longer outweigh its risks. The painkiller has been linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana. The panel voted 18 to 8 that the drug’s benefits do not […]
Pacira touts Phase IV study of Exparel anesthetic in total knee arthroplasty
Pacira Pharmaceuticals (NSDQ:PCRX) said today the Phase IV study of its Exparel bupivacaine liposome injection in patients undergoing total knee arthroplasty met its co-primary endpoints for postsurgical pain and opioid reduction. The anesthetic achieved statistical significance for secondary endpoints including time to 1st opioid use and the percentage of patients who did not require opioids […]
Minimally-invasive migraine treatment for adults works on kids, too
Migraine treatment that has been safe for adults has recently proven to be safe for use in children as well. The minimally-invasive treatment only takes a few minutes for children and teenagers to be able to feel the effects. The treatment involves a sphenopalatine ganglion (SPG) block that does not need needles. It uses a […]
Pacira prices $300m senior notes offering
Pacira Pharmaceuticals (NSDQ:PCRX) said today that it priced $300 million of convertible 2.375% senior notes due 2022 in a private placement to qualified institutional buyers. The Parsippany, N.J.-based company also gave purchasers a 30-day option to buy an additional $45 million aggregate principal amount of notes. Get the full story at our sister site, Drug Delivery […]
AcelRx Pharmaceuticals gains on Q4 earnings
Shares in AcelRx Pharmaceuticals (NSDQ:ACRX) rose today after the pharmaceutical company met expectations on Wall Street with its 4th quarter results. The Redwood City, Calif.-based company pared its losses to -$9.7 million, or -21¢ per share, on sales of $6.4 million for the 3 months ended Dec. 31, for bottom-line growth of 8.2% on sales growth of […]
FDA accepts AcelRx’s NDA for Dsuvia pain reliever
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]
Adapt Pharma seeks regulatory nod for naloxone nasal spray in Europe
Adapt Pharma said today that it filed a European Marketing Application for its naloxone hydrochloride nasal spray for the treatment of opioid overdose. The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in an 0.1 mL nasal spray and does not require assembly prior to use, according to […]
Fresenius Kabi launches Dilaudid injection in Simplist prefilled syringes
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that its Dilaudid hydromorphone HCl injection is available in 4 different presentations of the Simplest prefilled syringes. The Lake Zurich-Ill. company’s Simplist syringes have a 2-year shelf life and do not require any assembly or point-of care preparation. Get the full story at our sister site, Drug Delivery Business […]
AcelRx touts Dsuvia data for burn victims
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it plans to present data from a study evaluating its Dsuvia pain reliever in patients with moderate-to-severe acute pain resulting from trauma or injury. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator. Dsuvia is investigational and not approved in […]
FDA accepts Flexion’s NDA for osteoarthritis steroid injection
Flexion Therapeutics (NSDQ:FLXN) said today that the FDA accepted its New Drug Application for Zilretta – its extended-release steroid injection. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection in 2015. Flexion touts Zilretta as the 1st intra-articular, extended-release therapy for patients with knee osteoarthritis pain. The injection uses microsophere technology […]