October 8, 2024: Promising schizophrenia drug approved; tirzepatide (Mounjaro and Zepbound) no longer in shortage; real-world performance of Ozempic; breast cancer podcast; healthy tips
New Drug Approvals: Cobenfy for Schizophrenia
For the first time in 70 years, a new type of schizophrenia treatment has been approved in the U.S.: Bristol Myers Squibb’s twice-daily Cobenfy (xanomeline trospium chloride) pill. One of Cobenfy’s two active ingredients, xanomeline, was initially studied in the 1990s as a treatment for Alzheimer’s. Although the cognitive benefits of the drug were apparent, intense side effects led many participants to drop out of the trials and the drug research was scrapped. More than a decade later, it was discovered that trospium chloride, when combined with xanomeline, provided relief from hallucinations and other psychiatric symptoms without all the side effects of xanomeline alone.
Traditional drugs for schizophrenia that block dopamine receptors, such as chlorpromazine (approved in 1954), and newer “atypical” antipsychotics like Zyprexa and Invega, can lead to movement disorder side effects like tardive dyskinesia and lethargy. Cobenfy works by stimulating cholinergic receptors called acetylcholine, a nerve cell chemical that carries messages from your brain to your body. Cobenfy offers a much better side effect profile, without the tics, weight gain, and sleepiness that often occurs with traditional antipsychotics.
FDA press release: https://www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism-action-treatment-schizophrenia
Read about the history of Cobenfy’s development, from xanomeline as an Alzheimer’s candidate to the investigational KarXT version to the branded Cobenify:
https://www.fiercepharma.com/pharma/bmss-newly-approved-schizophrenia-drug-cobenfy-what-long-strange-trip-its-been
John H. Krystal, MD at Psychiatric Times, explains why this is a historic moment in the treatment of schizophrenia. (7 minutes)
https://www.psychiatrictimes.com/view/the-fda-approval-of-cobenfy-a-historic-moment-in-schizophrenia
While Cobenfy sounds promising, only two short-term clinical trials were used as the basis for its approval. Also, the drug has its own set of side effects, as MedShadow’s Jessica DiGiacinto explains.
https://medshadow.org/cobenfy-fda-approval-what-to-know/
Here are some patient ratings and reviews for traditional schizophrenia treatments: Invega, Zyprexa, Seroquel, Abilify, Geodon or Risperdal.
Expanded Approvals for Dupixent and Tagrisso
Sanofi and Regeneron Pharmaceuticals’ eczema drug Dupixent received expanded approval for inadequately controlled chronic obstructive pulmonary disease (COPD) .
https://medcitynews.com/2024/09/sanofi-regeneron-copd-dupixent-fda-approval-biologic-drug/
AstraZeneca received expanded approval of Tagrisso (osimertinib) for stage 3 breast cancer.
https://news.askapatient.com/i/149881124/tagrisso-osimertinib-mesylate-tablets
GLP-1 Drugs News
Health policy journalist Joshua Cohen presents some research suggesting that in the real world, long term benefits of GLP-1 drugs (like Ozempic and Victoza) may be inferior to what is reported in controlled clinical trial settings. For example, a study published recently in the Journal of the American Medical Association showed that Type 2 diabetes and obesity patients achieved an average weight loss of 3.7% one year after starting on medications. However, this result included those who stopped using the drugs during the course of the year. Also, those taking liraglutide injections (such as Victoza or Saxenda) had less weight loss than those taking semaglutide injections (such as Ozempic or Wegovy).
Cohen says that one pharmacy claims company found that discontinuation can be as high as 85% by the end of two years of treatment.
https://www.forbes.com/sites/joshuacohen/2024/10/02/weight-loss-from-glp-1-drugs-not-as-robust-in-real-world-settings/
The figure below is titled “Mean Percentage Weight Reduction by Agent From Initiation of Medication Use During Study Follow-Up” and shows greater weight loss for semaglutide than for liraglutide over the course of 18 months.
(Image source: Gasoyan H, Pfoh ER, Schulte R, Le P, Butsch WS, Rothberg MB. One-Year Weight Reduction With Semaglutide or Liraglutide in Clinical Practice. JAMA Netw Open. 2024;7(9):e2433326. doi:10.1001/jamanetworkopen.2024.33326) open access article distributed under the terms of the CC-BY license.
FDA Says Mounjaro and Zepbound No Longer in Shortage
Eli Lilly’s Mounjaro (tirzepatide for Type 2 diabetes) and Zepbound (tirzepatide for weight loss) are no longer in shortage, according to an FDA announcement. Since 2022, compounding pharmacies have helped meet demand by making copies of the treatments (which are not approved by the FDA) and selling them at a fraction of the brand name price. With the shortage over, the compounding pharmacies will no longer be allowed to make and sell those drugs.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
The trade group that represents compounding pharmacies, the Outsourcing Facilities Association is suing the FDA for taking tirzepatide off the drug shortage list. They claim that the drug is still in short supply and that the FDA did not give the public a chance to weigh in on its decision to remove the drug from the list.
https://www.reuters.com/legal/compounding-group-sues-fda-removing-lillys-weight-loss-drug-shortage-list-2024-10-07/
In July 2024, the FDA issued a warning about dosing errors that may occur when patients use compounded versions of the GLP-1 drugs. Unlike the branded products that are packaged as pre-measured one-dose injection pens, compounded medications often come in vials that patients must measure before inserting into a syringe.
https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded
Anti-Nausea Drugs
Have you ever had problems getting the medications you need, not because the drugs are in short supply, but because of your insurance company’s coverage limits? Reuters reports that this happens to cancer patients who rely on an anti-nausea drug called ondansetron (Zofran brand name) while they are going through chemotherapy. Oncologist Dr. Fumika Chino likes to prescribe her patients with 90 tablets of ondansetron, enough to take the drug three times a day for a month if needed. But patients may only be able to get 21 or 30 tablets at a time and some have to ration their pills or use a less effective medication until they can get a refill. Pharmacy benefit managers say the limits guard against overuse, and that they offer workarounds to get more tablets.
https://www.newsbreak.com/the-associated-press-510077/3590818678412-limits-to-anti-nausea-pill-coverage-wear-on-cancer-patients-and-doctors
Read or add your patient ratings for Zofran and Zofran ODT at AskaPatient
Podcast Recommendation: History of Breast Cancer Treatment
"The Knife is the Cure" is the second installment of Dr. Stacy Wenworth's "Less Radical," her podcast series about Dr. Bernie Fisher, the surgeon-scientist who paved the way for less radical treatments to become the standard of care for breast cancer. The second episode tells the story of Dr. William Halsted, a pioneer of modern surgery who practiced in the late 19th and early 20th century.
In a “bonus episode” called "The Other Side of the Knife,” Dr. Wentworth shares the stories of women who underwent radical mastectomies back when that was the only treatment for breast cancer available. She begins by describing the surgical ordeal experienced on October 8, 1811 by Nabby Adams Smith, the eldest child of John and Abigail Adams. The episode also features prominent women of the 1970s who spoke out about their breast cancer and treatments. Journalist Rose Kushner was an activist who insisted on being awakened after her biopsy (normally this wasn’t done; the patient would not know until she woke up from surgery if her breast had been removed) so that she could find out the result and decide for herself how to proceed. The program also includes audio clips from breast cancer survivors Betty Ford, Ruth Handler (creator of Barbie), Shirley Temple Black, Erma Bombeck, and others.
Both episodes are about 25 minutes long, and are also available on other podcast platforms.
Healthy Tips: Kombucha Beverage
Ever try kombucha, the fermented drink made from tea and SCOBY (symbiotic culture of bacteria and yeast)? It is full of antioxidants and probiotics, and you can make it yourself or find it in the refrigerated drinks section at a grocery store. As “The Checkup” explains, fans of kombucha say the drink can lower blood sugar, improve cholesterol, boost mood, detoxify the liver, and more. But is kombucha safe for everyone? Learn more about this unique and increasingly popular beverage.
https://www.singlecare.com/blog/kombucha-benefits/
Did you miss this week’s Drug Safety Updates? Check it out here:
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