Valentine’s Day is a great day for creating that tingly feeling, but Abbott Park, Ill.-based Abbott Laboratories believes that this is not a good sensation for patients who are in search of pain relief via spinal cord stimulation (SCS) devices. Thus, the company touts its Proclaim Plus as a system that delivers a tightly titrated charge to multiple sites on the spinal cord to generate an analgesic effect without that tingling sensation, an outcome the company said is preferred by 87% of those in need of SCS for pain relief.
Dyansys Inc. obtained its second greenlight from the FDA this month for its Primary Relief device to alleviate pain following caesarean-section birth. The company received 510(k) clearance for its First Relief system for painful diabetic neuropathy on July 18. Both systems stimulate nerves on the outer surface of the ear using a percutaneous electrical nerve stimulator (PENS) system.
In two separate studies, researchers have identified how peripheral nerve injury can lead to increased pain sensitivity. The studies were published on May 25, 2022, in Nature and May 26, 2022, in Science, respectively. The mechanisms they identify could lead to new therapeutic approaches to chronic pain and/or pain hypersensitivity.
More than 10% of Americans suffer from chronic pain, and how to prevent acute pain from turning chronic has been a critical question in pain research. But according to a study published in the May 11, 2022, issue of Science Translational Medicine, that approach has it backwards. In several animal models of pain, the resolution of acute pain was an active process. Chronic pain happened when those active processes failed to occur.
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane in various solid tumors and paired with Xtandi in metastatic prostate cancer.
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic.
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic.
DUBLIN – Shares in Bone Therapeutics SA dropped by as much as 38% Aug. 30 after the regenerative medicine firm reported that its lead program, JTA-004, flopped in a phase III trial in osteoarthritis of the knee. The candidate therapy, designed to lubricate and protect damaged cartilage in affected joints, failed to meet the primary endpoint of being superior to placebo in reducing pain, as measured on the Western Ontario McMaster Universities Osteoarthritis Index (Womac) pain subscale three months after treatment.
Medtronic plc snagged FDA premarket approval for its recharge-free implantable neurostimulator (INS), Vanta, for patients with intractable pain. The spinal cord stimulator offers up to 11 years of device life, with optimal programming. That represents a 10% improvement on the Dublin-based company’s previous longest-lasting INS, Primeadvanced, and a near doubling of device life compared to Abbott Laboratories’ Proclaim and Boston Scientific Corp.’s Wavewriter Alpha, using the settings recommended in the clinician manuals.
It took a few years and three tries, but Heron Therapeutics Inc. finally got its pain drug, HTX-011, now branded Zynrelef, over the FDA finish line. Even so, the approval comes with a less broad label than Heron would have liked. Zynrelef (bupivacaine and meloxicam), which had a May 12 PDUFA date, is approved for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
