More than four years after it was given the authority to do so, the FDA is requiring manufacturers of opioid painkillers dispensed in outpatient settings to make prepaid mail-back envelopes available to pharmacies and other dispensers as part of their risk evaluation and mitigation strategy (REMS).
Researchers at Indiana University Bloomington have developed allosteric modulators of the opioid receptor that were superior to the opioid antidote naloxone at blocking the effects of fentanyl in vitro. They presented their work in a session on “Progress towards more efficacious medicine: Antibiotics and antidotes” at the 2023 spring meeting of the American Chemical Society (ACS).
Free, no-prescription-required access to naloxone injectors and nasal sprays has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Many times, unfortunately, opioid users are alone when an overdose occurs. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed.
Mainstay Medical Holdings plc released data from a one-year, real-world, study of patients implanted with a neurostimulation device to treat chronic lower back pain.
Neuropeptide FF receptor 1 (NPFFR1) and NPFFR2 regulate several biological functions and there is a lack of blockers for these receptors that allow the study of their function. Université de Strasbourg researchers have presented details on the design of RF-3286, an NPFFR1 antagonist for the potential treatment of hyperalgesia.
A research team led by assistant professor Min-Ho Seo of Busan, South Korea’s Pusan National University have developed a soft, bioresorbable, implantable device to relieve neuropathic pain by cooling peripheral nerves.
It’s not a done deal yet, but Teva Pharmaceutical Industries Ltd. has agreed in principle to pay up to $4.25 billion, plus about $100 million to Native American tribes, to end most of the lawsuits it’s facing across the U.S. over its opioid sales. The figure includes settlements the company already has made with some state and local governments, as well as the supply of up to $1.2 billion worth of Teva’s generic naloxone nasal spray.
A U.S. federal jury breathed new life into so-called pay-for-delay settlements when it found that a 2010 agreement between Endo International plc and Impax Laboratories LLC was procompetitive as it allowed Impax to launch its generic version of Opana ER, an opioid pain drug, before key patents expired.
Winding down its current term, the U.S. Supreme Court on June 13 declined to hear appeals filed by Insys Therapeutics Inc. founder John Kapoor and former regional sales director Sunrise Lee.
A lengthy trial over two generic drug manufacturers’ alleged role in fueling the opioid epidemic in West Virginia came to an end this week when the U.S. affiliate of Teva Pharmaceuticals Ltd. and Allergan, now part of Abbvie Inc., agreed to a settlement totaling more than $161.5 million.
