Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Approves Migraine Nasal Spray Zavzpret
CBS News: Pfizer Migraine Nasal Spray Zavzpret Wins FDA Approval
Pfizer said Friday that the Food and Drug Administration has approved a new nasal spray to treat migraines. Zavzpret, a branded formulation of the generic drug zavegepant, is the "first and only" calcitonin gene-related peptide receptor antagonist nasal spray for treating migraines with or without an aura, or sensory disturbances such as flashes of light that can accompany a migraine, the drugmaker said. Zavzpret began working to treat migraine symptoms in as little as 30 minutes and provided some relief for up to 48 hours after the last administered dose, Pfizer said, citing a March study published in The Lancet. (Napolitano, 3/11)
Stat: FDA Approves First Treatment For Rett Syndrome
The Food and Drug Administration on Friday approved the first treatment for Rett syndrome, a genetic disease mostly affecting girls that causes severe neurologic impairments, robbing them of the ability to communicate or control muscle movement. (Feuerstein, 3/11)
NPR: Statin Alternative Lowers Cholesterol And Heart Attack Risk Without Muscle Pain
When the FDA approved bempedoic acid, marketed under the brand name Nexletol, back in 2020, it was clear that the drug helped lower LDL — "bad" cholesterol. The drug was intended for people who can't tolerate statin medications due to muscle pain, which is a side effect reported by up to 29% of people who take statins. What was unknown until now, is whether bempedoic acid also reduced the risk of cardiovascular events. Now, the results of a randomized, controlled trial published in The New England Journal of Medicine point to significant benefit. The study included about 14,000 people, all of whom were statin intolerant. (Aubrey, 3/13)
Also —
CIDRAP: When Medical Visits Are Shorter, Patients More Likely To Get Unneeded Antibiotics
A study of US medical record data found that shorter primary care visits were linked to a higher likelihood of inappropriate antibiotic prescribing for respiratory infections. The findings, published today in JAMA Health Forum, are part of a larger study investigating whether clinicians make less-appropriate prescribing decisions in shorter visits. In addition to a higher likelihood of inappropriate antibiotics, the researchers also found that shorter visits were associated with a higher likelihood of inappropriate co-prescribing of opioids and benzodiazepines for pain, which can increase the risk of overdose. (Dall, 3/10)
The New York Times: How An Opioid Settlement Hinders Patients’ Access To ADHD Medication And Other Drugs
Nearly a year after a sweeping opioid settlement imposed new requirements on the companies that provide medications to pharmacies, patients across the United States are having difficulty obtaining drugs to treat many conditions, including anxiety, attention deficit hyperactivity disorder and addiction. The $21 billion settlement, which was brokered between the three largest American pharmaceutical distributors and the attorneys general of 46 states, was designed in part to correct practices that had flooded the country with prescription painkillers, contributing to the nation’s opioid crisis. Distributors are placing stricter limits on drug supplies to individual pharmacies and heavily scrutinizing their dispensing activity. (Jewett and Gabler, 3/13)
Stat: Biogen Executive Samantha Budd Haeberlein Leaves Company
Samantha Budd Haeberlein, the Biogen senior executive who supervised the development and controversial approval of the Alzheimer’s treatment Aduhelm, has left the company, STAT has learned. (Feuerstein and Garde, 3/12)
North Carolina Health News: Erendira Needs A Kidney
Erendira’s family immigrated to the U.S. from Mexico when she was 12. Her mom worked as a cleaner, including at a dialysis center. There, Erendira would sometimes come and help her mom mop. But the facility always made her feel uneasy — something about the rows of hulking machines that sucked the blood out of a body, cleaned it and put it back in. “I would always tell my mom, ‘Oh, that would be the scariest thing. I would never want to be on dialysis,’” she remembered. (Donnelly-DeRoven, 3/13)
