PRODUCT NEWS | DEPARTMENTS
individuals aged 12 and older. Nalmefene, an opioid receptor antagonist, comes in a pre-filled auto-injec - tor delivering 1.5 mg per dose, designed for subcuta- neous or intramuscular use. This approval, which received fast-track and prior- ity review designations, supports broader access to opioid overdose reversal agents. The injection can rapidly counteract symptoms such as respiratory depression and low blood pressure. It is available by prescription and can be administered by healthcare professionals, first responders, and even bystanders. Purdue Pharma plans to distribute it at no profit to help address the opioid crisis. symptoms compared to placebo over four weeks. Vonoprazan provided all-day and all-night relief, with the treatment group experiencing significantly more heartburn-free days. The study included 772 adults who experienced heartburn at least four days a week. The results were presented at Digestive Disease Week 2024 and published in Clinical Gastroenterology and Hepatology. Common adverse effects included abdominal pain, consti - pation, diarrhea, nausea, and urinary tract infec- tions, with upper respiratory infections and sinusitis reported during a 20-week extension period.
FDA APPROVES NALMEFENE FOR OPIOID OVERDOSE The FDA has approved nalmefene injection (Zurnai) for emergency treatment of opioid overdoses in VONOPRAZAN APPROVED FOR NONEROSIVE GERD The FDA has approved vonoprazan (Voquenza) 10 mg tablets for treating heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. This approval marks the third FDA approval for vonoprazan, which is also approved for treating erosive esophagitis and Helicobacter pylori infection when combined with antibiotics. The decision was based on the positive results of the PHALCON-NERD-301 study, which demon - strated significant and quick reduction in heartburn
FDA GREENLIGHTS KISUNLA FOR EARLY ALZHEIMER'S The FDA has approved donanemab-azbt (Kisunla), a groundbreaking amyloid plaque-targeting therapy for early symptomatic Alzheimer's disease. This therapy, which received Fast Track Review, Priority Review, and Breakthrough Therapy designations, is designed for adults with mild cognitive impair- ment or mild dementia stages of Alzheimer’s with confirmed amyloid pathology. Administered once a month, Kisunla works by removing amyloid plaque buildup, which is associated with Alzheimer’s pro- gression. The approval was based on data from the phase 3 TRAILBLAZER-ALZ 2 trial, which involved 1,736 participants. The study showed significant cognitive and functional improvements in patients treated with donanemab compared to those given a placebo. Specifically, the treatment group exhibited a 39% lower risk of progressing to the next stage of the disease and demonstrated considerable reductions in amyloid plaques over time. Kisunla’s ability to potentially halt treatment once amyloid plaques are sufficiently removed offers a cost-effective and less burdensome option for patients. However, the therapy carries risks such as amyloid-related imaging abnormalities (ARIA) and other infusion-related reactions. Ongoing stud- ies are exploring the prevention of symptomatic Alzheimer's and further understanding ARIA.
NEW CONTINUOUS GLUCOSE MONITORS GET FDA NOD The FDA has approved two new over-the-counter (OTC) continuous glucose monitoring (CGM) sys- tems from Abbott: the Lingo and Libre Rio. These devices are based on Abbott’s FreeStyle Libre tech- nology, widely recognized in the CGM market. The Lingo CGM is designed to help adults understand their health better and enhance their wellness, while the Libre Rio is tailored for adults with type 2 dia- betes who manage their condition without insulin, focusing on lifestyle modifications. The Libre Rio can detect a wide range of glucose levels (40-400 mg/dL) and is intended to improve glucose control, reduce HbA1c, and lower diabetes-related hospital admissions. Both devices use a biosensor worn on the arm, providing continuous glucose data via a smartphone app, offering insights into food reac - tions, exercise, and stress.
FDA WEIGHS BAYER’S HOT FLASH TREATMENT Bayer has submitted a new drug application (NDA) to the FDA for elinzanetant, a nonhormonal treatment targeting moderate to severe vasomo- tor symptoms, such as hot flashes, associated with menopause. Elinzanetant, a dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, works by modulating estrogen-sensitive neurons in the hypo- thalamus, thereby regulating body heat control and reducing menopause-related symptoms. Data from three phase 3 clinical trials (OASIS 1, 2, and 3) demonstrated that elinzanetant significantly
reduced the frequency and severity of hot flashes and improved sleep disturbances and overall quality of life. The most common side effects were head - aches and fatigue. This FDA submission marks a significant milestone in offering a new treat - ment option for women experiencing menopause, addressing a critical gap in available therapies.
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