Bulletin Today
APhA staff
FDA approves first S.C. infusion device for patients with Parkinson’s disease
On February 4, 2025, FDA approved Onapgo (apomorphine hydrochloride), a wearable infusion device, available soon in the United States for adults with advanced Parkinson’s disease.
Onapgo is the first and only S.C. apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. The wearable technology has a proven history in Europe for over 30 years of delivering continuous medication throughout the day to adults with advanced Parkinson’s disease and will now be available to Americans for the first time.
Nearly one million Americans live with Parkinson’s disease, experiencing significant challenges such as dyskinesia, as well as tremors, muscle rigidity, and difficulty with movement and balance that can significantly interfere with daily activities.
Continuous treatment with Onapgo helps to control motor fluctuations common among patients in the advanced disease stage.
Approval was based on results from a phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study that showed the device significantly reduced daily episodes when treatment with oral levodopa was not working optimally for patients, compared with placebo, and when the device improved times when oral levodopa was working effectively.
Users were also more likely to report improvement in their overall health compared with controls. Common adverse events experienced by those taking Onapgo included nausea, somnolence, headache, insomnia, dyskinesia, and infusion-site issues. ■
Increase seen in pediatric exposure to caffeine energy products
Caffeine is the most consumed psychostimulant in the world and multiple health organizations, including the American Academy of Pediatrics, warn that there is no safe amount of energy drink consumption for children and adolescents.
Over 32,000 caffeine energy product exposures in children and adolescents were reported to U.S. poison centers from 2011 through 2023, revealing an increase in exposure rate of 17%.
A study published on January 31, 2025, in the Journal of Medical Toxicology investigated the characteristics and trends of pediatric exposures to caffeine energy products reported to U.S. poison centers from 2011 to 2023. Most exposures were in children younger than age 6 years (69.6%), males (56.7%), or involved liquid formulations (57.5%). Popular energy drink products commonly contain 160 mg of caffeine in a 16 oz serving, but energy drinks with concentrations up to 300 mg per 16 oz are available. Two energy shot products identified in this study contained 200 mg and 230 mg of caffeine per serving.
Although most cases were not treated in a health care setting, about 1.6% of the cases were medically admitted. Compared with younger children, individuals aged 13 to 19 years were more likely to be medically admitted or have serious medical outcomes. The authors concluded that there are opportunities to reduce the adverse effects of caffeine products among the pediatric population. ■
Migraine treatment for adults has a new arrow in the quiver
On January 30, 2025, FDA approved Symbravo, a combination of meloxicam and rizatriptan, for the acute treatment of migraine with or without aura in adult patients.
Migraine can be a debilitating condition that affects millions of Americans, about one in four households. They can last from 4 to 72 hours if untreated, and the frequency of migraines vary per person. Having options for treatment that are both safe and well-tolerated creates a need for novel migraine medicines.
The approval of this new acute treatment is based on the results of the Phase III MOMENTUM trial, which included patients with migraines of moderate and severe pain intensity; the Phase III INTERCEPT trial, which treated migraine when the initial pain was mild; and the Phase III MOVEMENT long-term open safety trial. In all, more than 21,000 migraine attacks were treated with meloxicam/rizatriptan.
Somnolence and dizziness were the most common adverse reactions in the studies. Symbravo is available in 20 mg meloxicam/10 mg rizatriptan tablets and includes a boxed warning for risk of serious cardiovascular and GI adverse events. Symbravo is expected to be available by Spring 2025. ■
Expanding access to contraception in New England
Connecticut residents now have greater access to contraceptives thanks to new initiatives and educational programs for pharmacists.
Developed by the University of Connecticut School of Pharmacy and approved by the state Department of Consumer Protection on January 31, 2025, the continuing education program is for licensed pharmacists interested in prescribing hormonal birth control directly to customers.
Pharmacists are uniquely positioned to provide essential health care services due to more frequent interactions with patients than physicians and to serve as stewards for safe and effective medication use.
Over 6,500 pharmacists in Connecticut can take the course and offer contraceptive services, increasing access to fundamental health care. Connecticut has also rolled out its first vending machines including emergency contraception and other OTC medications.
Pharmacists who want to prescribe contraception can register for the on-demand training program by visiting the UConn School of Pharmacy website. The cost to pharmacists is $40 for registration. Once a pharmacist completes the training, they will be able to prescribe contraception. The course counts toward the 15 hours of annual continuing education required for pharmacists. ■