November 26, 2023: four cancer drug approvals; osteoarthritis study; addiction treatments; PBMs slash pharmacy reimbursements; manufacturing safe drug ingredients
Drug Approvals
The U.S. Food and Drug Administration (FDA) approved Astra Zeneca's Truqap (capivasertib) for use in combination with Faslodex (fulvestrant ) to treat patients with HR-positive, HER2-negative advanced breast cancer that has at least one of three gene alterations—PIK3CA, AKT1 and PTEN. FDA also approved the FoundationOne CDx assay as a companion diagnostic tool to identify patients with this type of breast cancer.
https://www.fiercepharma.com/pharma/astrazenecas-first-class-truqap-approval-breast-cancer-marred-surprise-restriction
Astellas Pharma's prostate cancer drug Xtandi (enzalutamide) received expanded approval to treat nonmetastatic castration-sensitive prostate cancer with high risk for metastasis. Previously, it was only for metastatic forms of the cancer. It is used in combination with the luteinizing hormone-releasing hormone (LHRH) leuprolide. https://www.targetedonc.com/view/behind-the-fda-approval-of-enzalutamide-for-prostate-cancer
Merck’s Keytruda (pembrolizumab) was approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced HER2-negative gastric or gastroesophageal junction (GEJ) cancer.
https://www.curetoday.com/view/fda-approves-keytruda-plus-chemo-for-advanced-her2-negative-gastric-gej-cancers
The FDA approved Bristol-Myers Squibb's Augtryo (repotrectinib) for treating advanced ROS1-positive non-small cell lung cancer (NSCLC).
https://www.ajmc.com/view/fda-approves-augtyro-for-locally-advanced-or-metastatic-ros1-positive-nsclc
Safety Label Updates
Boehringer Ingelheim's Pradaxa (Dabigatran), a drug for preventing blood clots, had a safety label update to report on postmarketing experiences of patients that include gastrointestinal, immune system, renal and urinary, blood, and skin/hair disorders (alopecia).
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1474
Patient reviews of Pradaxa on Ask a Patient website
Rheumatoid arthritis generic drug methotrexate's safety label was revised to warn of injection site reactions and necrosis.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1481
Patient reviews of methotrexate on Ask a Patient website
AstraZeneca's cancer drug Lynparza (olaparib) had a safety label update to warn that Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients and some cases were fatal.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1421
Patient review of Lynparza on Ask a Patient website
Drugs & Treatments Research
A Monash University-led study found that a common, affordable existing drug, methotrexate, can help with pain from osteoarthritis in the hand. A 20mg weekly oral dose over six months had a moderate effect in reducing pain and stiffness in patients with symptomatic hand OA. The results of the six month study were published in the Lancet.
https://www.monash.edu/news/articles/common-drug-can-improve-hand-osteoarthritis-symptoms-study
Scientists from start-up Navega Therapeutics are studying a CRISPR-based painkiller called "Long-Lasting Analgesia via Targeted Epigenetic Repression." In their study, mice were exposed to various chronic pain-causing stimuli, including chemotherapy and inflammatory drugs. The mice who were treated with the epigenetic editing technique had a significant drop in sensitivity to pain for both types of stimuli. The study was published in Science Translational Medicine. Check out Beyond Bio’s explanation of innovative research on CRISPR treatment for chronic pain.
Adults with mild hearing loss have double the risk of falling, according to a new study. Researchers at UCHealth in Colorado found that older adults who consistently wear hearing aids had a 50% lower incidence of falling. NPR interviewed Laura Campos, an audiologist and lead researcher at UCHealth. The study was published in the Journal of the American Geriatrics Society.
https://www.npr.org/sections/health-shots/2023/11/13/1212051086/hearing-aids-hearing-loss-falls-injury-aging-older-adults
A study by Northwestern University, Vanderbilt University Medical Center and the University of Alabama at Birmingham found that everyone, even people currently on blood pressure-reducing drugs, can reduce their blood pressure by eating less salt. “In the study, middle-aged to elderly participants reduced their salt intake by about one teaspoon a day compared with their usual diet. The result was a decline in systolic blood pressure by about six millimeters of mercury (mm Hg), which is comparable to the effect produced by a commonly utilized first-line medication for high blood pressure,” said Deepak Gupta, MD, associate professor of medicine at Vanderbilt University Medical Center and co-principal investigator. The study was published in JAMA.
https://news.feinberg.northwestern.edu/2023/11/13/cut-salt-cut-blood-pressure/
Overdose Deaths Continue to Spike
The Centers for Disease Control and Prevention (CDC) reports that more than 111,000 drug-overdose deaths occurred in the U.S. in the 12-month period ending in April 2023, with more than 77,000 of those involving fentanyl and other synthetic (man-made) opioids. Fentanyl is 50 times more potent than heroin and 100 times more potent than morphine. Additional lethal drugs are increasingly occurring in the overdose mix. A study published in the journal Addiction by UCLA School of Medicine found that the proportion of overdoses involving fentanyl and a stimulant (often cocaine or methamphetamine) increased more than fifty-fold from 2010 to 2021. Researchers say this represents a new fourth wave of overdose deaths.
Wave 1 involved deaths involving prescription opioids (started in the 1990s); Wave 2 involved heroin deaths (started in 2010), and Wave 3 started when people died from overdoses of synthetic opioids like Fentanyl (started in 2013), and Wave 4 involves overdose deaths involving Fentanyl with stimulants (started in 2015). https://www.nbcnews.com/health/health-news/fentanyl-stimulants-drives-fourth-wave-overdose-epidemic-us-rcna104953
KFF News investigated the drug addiction problem in Vermont, where more medication is prescribed for opioid use disorder per capita than in any other state. Vermont's Hub and Spoke program puts prescription medicines at the center of treatment strategy. However, addiction treatments like Suboxone (buprenorphine), naloxone, and methadone aren't as effective with fentanyl, xylazine, and stimulants. “There was a time when we couldn’t have pictured things being worse than heroin,” said Jess Kirby, director of client services for Vermonters for Criminal Justice Reform, which offers services to counter substance use disorder. “Then we couldn’t picture things being worse than fentanyl. Now we can’t picture things being worse than xylazine. It keeps escalating.”
https://kffhealthnews.org/news/article/overdose-opioid-use-disorder-synthetic-drugs/
Multiple medications are often prescribed to manage drug withdrawal symptoms. These include ondansetron and promethazine for vomiting and nausea, loperamide and Lomotil for diarrhea, hydroxyzine and doxepin for itching, benzodiazepines and melatonin for insomnia, and benzos, tricyclic antidepressants (TCAs), and various serotonergic agents for anxiety. Taking multiple medications comes with increased risk of adverse drug-drug interactions. Researchers at University of Texas propose that an alternative single medication, mirtazapine, a tetracyclic antidepressant, can manage multiple symptoms of opioid withdrawal. The study was published in Cureus.
https://www.cureus.com/articles/178338-mirtazapine-a-one-stop-strategy-for-treatment-of-opioid-withdrawal-symptoms
Patient reviews of mirtazapine on Ask a Patient website
Patient reviews of Remeron (mirtazapine) or Remeron Soltab on Ask a Patient website
Drug Policy News
Amid unprecedented demand for the new RSV prevention drug for infants, the Centers for Disease Control and Prevention (CDC) announced the release of more than 77,000 additional doses of Beyfortus (nirsevimab-alip), a long-acting monoclonal antibody designed to protect infants against severe respiratory syncytial virus (RSV) disease. These additional doses will be distributed immediately to physicians and hospitals through the Vaccines for Children Program and commercial channels.
https://www.cdc.gov/media/releases/2023/p1116-rsv-doses.html
Pharmacists say that the Biden administration’s first major step toward imposing limits on the pharmacy benefit managers (PBM) is backfiring. Under the current system, when a pharmacy fills a prescription, the PBM tells it what the patient owes and what the PBM will pay the pharmacy. The PBM aggregates these payments and sends a check later. Often, however, the PBM will deduct a "performance fee" from the pharmacy from these payments. Under the new rules, the "performance fees" must be paid upfront instead of after the fact. PBMs’ response has been to demand they accept new contracts with draconian cuts to their payments for dispensing medicines, said Ronna Hauser, vice president of the National Community Pharmacists Association, which represents independent drugstores. If pharmacies refuse the contracts, they risk losing Medicare customers.
Pharmacies, especially independent pharmacies not already connected to the PBM industry (for example, CVS has its own PBM and is also under then Aetna Health Insurance umbrella), find it hard to stay in business, and cannot offer customers expensive drugs like Ozempic. Doug Hoey, CEO of the National Community Pharmacists Association explains how PBMs are turning the new rules to their own advantage.
https://kffhealthnews.org/news/article/pharmacy-benefit-managers-pbm-rule-backfires-drug-pricing/
The People’s Pharmacy website featured an essay on how the FDA needs to change to regain public trust, written by retired pharmacist Dennis Miller. Miller's first suggestion: “FDA should explain why its definition of “safe and effective” is so vastly different from the layman’s definition.” Miller is the author of “The Shocking Truth About Pharmacy: A Pharmacist Reveals All The Disturbing Secrets.”
https://www.peoplespharmacy.com/articles/25-things-fda-must-do-to-rebuild-its-reputation
Check out our summary of recent news about what is happening to address drug quality safety concerns and drug shortages. This post includes a map of locations of U.S. and global API manufacturing establishments.
Active Pharmaceutical Ingredients Manufacturing for U.S. Drugs: Maps & Data
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