The US Food and Drug Administration (FDA) approved several drugs in August 2022 relevant to conditions often treated by nurse practitioners and PAs. Approvals include treatments for chronic idiopathic constipation, major depressive disorder, and testosterone replacement therapy.
Vibrant® for Chronic Idiopathic Constipation
Vibrant® is an orally-administered, drug-free capsule that received marketing authorization by the FDA for the treatment of chronic idiopathic constipation in adults. Chronic idiopathic constipation was defined as no relief of bowel symptoms despite treatment with laxative therapies for at least a month.
According to the manufacturer, Vibrant enhances colonic motility by mechanically stimulating the colon. The capsule is taken with water and then travels through the digestive system sending vibrations to stimulate motility. The capsule is directed by a pod, which activates and sends operating instructions to the capsule. A companion app is used to monitor treatment.
Authorization was supported by data from a clinical trial that compared the safety and efficacy of Vibrant to placebo in 312 patients with chronic idiopathic constipation.
Results indicated that 40.5% of patients treated with Vibrant achieved at least 1 bowel movement per week compared with 22.9% in the control arm of the study. Additionally, 23.4% of patients treated with Vibrant achieved at least 2 bowel spontaneous movements per week compared with 11.8% in the control arm.
No serious adverse reactions were reported. Vibrant is expected to be available in early 2023.
Auvelity™ for Major Depressive Disorder
The FDA approved Auvelity™ (dextromethorphan HBr-bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. Auvelity consists of dextromethorphan, a noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor that serves to increase the bioavailability of dextromethorphan by competitively inhibiting cytochrome P450 2D6. The exact mechanism of action of Auvelity in the treatment of MDD is unclear.
Approval was based on data from the randomized, double-blind, controlled phase 3 GEMINI and phase 2 ASCEND trials that evaluated the safety and efficacy of Auvelity in patients diagnosed with major depressive disorder.
Findings from the GEMINI trial showed that participants treated with Auvelity achieved superior improvement of depressive symptoms compared with placebo at week 6. In the ASCEND trial, 80 patients diagnosed with moderate to severe major depressive disorder were randomly assigned to receive either Auvelity or bupropion HCl (105 mg twice daily) for 6 weeks. Results showed that Auvelity met the primary endpoint demonstrating a statistically significant average mean reduction from baseline in the Montgomery–Åsberg Depression Rating Scale (13.7 points vs 8.8 points with bupropion; P <.001).
Auvelity will be supplied as 105-mg tablets in 30-count bottles and will be available in the fourth quarter of 2022.
Kyzatrex™ for Testosterone Replacement Therapy
The FDA approved Kyzatrex™ (testosterone undecanoate) for testosterone replacement therapy in men diagnosed with primary hypogonadism or hypogonadotropic hypogonadism.
The approval was based on data from an open-label, 6-month, phase 3 study that enrolled 155 men diagnosed with hypogonadism. Results showed that 88% of patients treated with Kyzatrex achieved a 24-hour mean plasma total testosterone concentration within the normal range of 222-800 ng/dL at day 90.
Kyzatrex carries a boxed warning regarding blood pressure increases that can lead to cardiovascular events including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death. The most common adverse reaction reported was hypertension.
Kyzatrex is supplied as 100 mg, 150 mg, or 200 mg of testosterone undecanoate capsules in 90-count bottles.
1. FDA grants marketing authorization for Vibrant a new drug-free treatment for adults with chronic constipation. News release. Vibrant Gastro Inc. August 30, 2022. Accessed September 14, 2022. https://www.einnews.com/pr_news/588483585/fda-grants-marketing-authorization-for-vibrant-a-new-drug-free-treatment-for-adults-with-chronic-constipation
2. Auvelity. Prescribing information. Axsome Therapeutics, Inc.; 2022. Accessed September 14, 2022. https://www.auvelity.com/prescribing-information.pdf
3. Kyzatrex. Prescribing information. Marius Pharmaceuticals; 2022. Accessed September 14, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213953s000lbl.pdf