April 30, 2023: FDA nod for unusual med for C. diff; migraine meds; ear infections in children; ALS. Research: probiotic reduces hangovers; cancer vaccines; sciatica surgery study; melatonin alerts
New Treatment for Prevention of C.diff Helps Rebalance the Gut Microbiome
Seres Therapeutics, Inc. and Nestlé Health Science's Vowst (fecal microbiota spores) treatment was approved by the U.S. Food and Drug Administration (FDA) to prevent recurrence of Clostridioides difficile (C. difficile) infection in adults age 18 and up who have already completed antibiotic treatment for the infection. Vowst is a capsule containing stool from a healthy donor and works by changing the balance of microorganisms in the gut. Vowst is the first fecal microbiota product to be taken orally: dosage is four capsules taken once a day for three consecutive days.
https://health.wusf.usf.edu/health-news-florida/2023-04-27/fda-approves-a-fecal-transplant-capsule-to-treat-c-diff-gut-infections
Read our complete post for more on the Vowst approval and learn about new products in the pipeline for for C.diff and ulcerative colitis.
https://askapatientnews.substack.com/p/new-fecal-microbiota-treatments-for-c-diff
New Treatment for Rare Type of ALS
Biogen's Qalsody (tofersen) was approved to treat SOD1-ALS, a rare version of amyotrophic lateral sclerosis (ALS, also known as Lou Gherig's Disease), a progressive neurodegenerative disease that attacks and kills the nerve cells that control voluntary muscles. Although between 16,000 and 32,000 Americans are currently living with ALS, the CDC estimates that fewer than 500 patients have SOD1-ALS in the U.S. Qalsody was approved under the accelerated approval pathway, so continued approval requires submission of clinical trial results to support its benefits. A trial is ongoing in individuals who are carriers of the SOD1 genetic mutation who do not yet have symptoms.
https://alsnewstoday.com/news/fda-approves-tofersen-now-qalsody-treatment-adults-sod1-als/
FDA Press Release
New Migraine Treatments
Migraine headache drugs continue to enter the pharmaceutical market: according to IntelGenx, the global market for migraine drugs was valued at nearly $3 billion in 2021 and is expected to reach nearly $11 billion by 2030.
IntelGenx's Rizafilm (rizatriptan benzoate) was approved for the treatment of acute migraine. Rizafilm is an oral thin film formulation of rizatriptan benzoate, the active ingredient in Merck's Maxalt migraine drug.
https://www.pharmaceutical-technology.com/news/fda-approves-intelgenxs-rizafilm-acute-migraine-treatment/
Read patient reviews for Maxalt (rizatriptan benzoate) shared on AskaPatient.
Abbvie's migraine drug Qulipta received expanded approval for the prevention of episodic migraine headaches. Previously it was only indicated for treating an episode of migraine. Qulipta was originally approved in September 2021.
https://www.news-journal.com/u-s-fda-approves-qulipta-atogepant-for-adults-with-chronic-migraine/article_ae8e46fa-2ab7-599b-823a-e047e40c0d40.html
Qulipta had a safety label change to add warnings about potential analyphlaxis and hpersenstivity reactions.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page
Pneumococcal Vaccine Approved for Pediatric Use
The FDA approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20, to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. It has also been approved for middle ear infection (otitis media) in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR.
https://www.pharmaceutical-technology.com/news/fda-pfizer-prevnar-20/
FDA Guidance for Developers of Quit-Smoking Treatments
The U.S. FDA released final guidance for drug sponsors in the clinical development of nicotine replacement therapy (NRT) products intended to help cigarette smokers stop smoking. “Through this guidance, we are encouraging innovation in NRT development by providing detail and clarity on product development strategies,” said Theresa Michele, M.D., director of the Center for Drug Evaluation and Research’s Office of Nonprescription Drug Products. The guidance outlines the development program for two new potential treatment regimens: 1) pretreatment before quit day, and 2) quitting by gradual reduction.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-final-nicotine-replacement-therapy-drug-products-guidance
The FDA guidance does not address how the increased use of vaping products by smokers trying to quit the cigarette habit affects potential new NRT. Natalie, a member of the nicotine addiction support group at the University of California San Francisco’s Fontana Tobacco Treatment Center, explains how she switched from traditional cigarettes to vaping but found the electronic version just as addictive and eventually decided to quit using nicotine completely. “I went from being an occasional cigarette smoker, a few a month, to a daily vaper.”
https://www.webmd.com/mental-health/addiction/news/20230428/youve-quit-smoking-with-vaping-now-what
Potential Drug Approval: Rexulti for Alzheimer’s Related Agitation
An FDA advisory committee recommended (by a 9-1 vote) approval of Rexulti (BREXPIPRAZOLE) to treat "Alheimer's disease related agitation." Currently, Rexulti is approved as an adjunct drug to treat major depressive disorder in adults and for treatment of schizophrenia in patients 13 and older. Rexulti contains a boxed warning for "Increased Mortality in Elderly Patients with Dementia-Related Psychosis." Alzheimer's disease is the most common cause of dementia.
https://www.fiercepharma.com/pharma/fda-advisory-committee-backs-lundbeck-and-otsukas-rexulti-use-alzheimers-disease-agitation-9
Read patient experiences with Rexulti shared at Ask a Patient.
Psychedelic Drug Therapy
Psychedelic drug therapy is gaining acceptance worldwide. In February 2023, Australia approved MDMA (a synthetic drug commonly known as Ecstacy or Molly) as a treatment for Post Traumatic Stress Disorder (PTSD). Other therapeutic psychedelics, including ketamine, ayahuasca, LSD (acid), psilocybin (the active ingredient in magic mushrooms) and other synthetic chemicals may be considered for approval in coming years. One analysis has projected that the psychedelics market could be worth more than $8 billion by 2028. Nature interviewed Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies.
https://www.nature.com/articles/d41586-023-01296-3
Investigation into EzriCare Artificial Tears Production Facility
The U.S. FDA, apparently for the first time, inspected the facility in India that was responsible for producing the EzriCare Artifical Tears that led to three deaths, eight reports of vision loss, and four reports of enucleation (surgical removal of eyeball). Inspectors found lack of sanitation, dirty equipment, and other safety problems at the Global Pharma Healthcare plant in Tamilnadu, India. The inspection took place from Feb. 20 to March 2, a few weeks after the company issued a recall of its EzriCare Artificial Tears because of contamination with extremely drug-resistant bacteria called P. aeruginosa. Citations were issued to Global Pharma Healthcare Pvt Ltd.
https://www.cbsnews.com/news/eye-drops-recall-factory-fda-inspection-global-pharma-healthcare/
Research News
Could a specially designed probiotic help prevent a hangover? When we drink alcohol, the liver breaks it down into less toxic byproducts using enzymes called alcohol dehydrogenases (ADH). Studies have found that a particular variant of the ADH1B enzyme appears to be especially potent at breaking down alcohol. Beijing Chinese Academy of Sciences researchers genetically engineered a version of Lactococcus lactis—a bacteria used to create dairy products like cheese —to contain the same version of the ADH that makes the potent ADH1B variant. Mice that were given this special probiotic about an hour before consuming alcohol experienced less drunkenness and recovered more quickly than the mice that didn't receive the probiotic. Some evidence also suggested that their livers and intestines were protected from alcohol injury. The study was published in Microbiology Spectrum.
https://gizmodo.com/probiotic-prevents-hangovers-mice-alcohol-study-1850329489
Surgery to relieve leg pain and disability in people with sciatica may be better than other non-surgical treatments, but the benefits are short-lived, lasting only up to 12 months, finds an analysis of the latest evidence by University of Sydney researchers. 24 studies were analyzed, and half of these investigated the effectiveness of discectomy compared with non-surgical treatment or epidural steroid injections (1711 participants). The study was published in BMJ.
https://www.ndcn.ox.ac.uk/news/surgery-for-sciatica-reduces-leg-pain-and-disability-but-benefits-are-short-lived
Sciatica refers to pain that travels along the path of the sciatic nerve, which travels from the lower back through the hips and buttocks and down each leg. Cleveland Clinic provides an overview of sciatica, a common condition which affects as many as 43% of people at some point in their lives.
https://my.clevelandclinic.org/health/diseases/12792-sciatica
A study by Mass General Cancer Center found that an individually customized cancer mRNA vaccine used in conjunction with cancer drug pembrolizumab (Keytruda) reduced the risk of relapse of melanoma by targeting up to 34 mutations. The vaccine must be designed specifically for each patient using cells obtained from a patient's tumor. The study was presented at American Association for Cancer Research's annual meeting.
https://www.floridatoday.com/story/news/health/2023/04/16/mrna-vaccine-cancer-melanoma-study/11623992002/
Researchers at Cambridge Health Alliance and University of Mississippi analyzed the content of melatonin in gummy products, and found inaccuracies in ingredient concentrations listed on product labels. Of the 25 brands included in the gummy study, 22 were inaccurately labeled and actually contained between 74% to 347% of the amount of melatonin advertised on the label. Only three out of 25 supplements matched the label within about 10% of the amount advertised, and one supplement actually contained CBD instead of melatonin. The research letter was published in JAMA Network.
https://www.cnet.com/health/nutrition/melatonin-content-in-gummy-form-could-be-a-gamble-study-suggests/
Melatonin products are considered dietary supplements, and are not approved or tightly regulated by the U.S. FDA. However, the FDA does collect reports of adverse reactions from dietary supplements.
https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
These third-party testers of dietary supplements include some gummy melatonin products in their databases:
NSF International:
https://info.nsf.org/Certified/Dietary/
Consumer Lab (requires membership):
https://www.consumerlab.com/reviews/melatonin-supplements/melatonin/?search=Melatonin#related-clinical-updates
Note: Consumer Reports suggests looking for the USP certification seal on dietary supplements you buy, as the U.S. Pharmacopeia sets the most widely accepted standards. A list of USP-verified products can be found at quality-supplements.org. However, when we checked, there were no melatonin gummies listed on the USP site.
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