The FDA recently approved a new oral tablet formulation of Wegovy® (semaglutide), marking the first available GLP-1 drug in an oral formulation.
GLP-1 drugs are a popular new class of drugs used for the treatment of diabetes and obesity. All other currently available GLP-1 drugs for the treatment of obesity come in injectable formulations. The availability of oral tablets could result in greater utilization of these drugs.
The new Wegovy oral tablets are indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in obese adults and overweight adults with at least one weight-related comorbidity. Additionally, the tablets are approved to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease who are either obese or overweight.
The new tablet formulation of Wegovy will be available in dosages of 1.5 mg, 4 mg, 9 mg, and 25 mg. The tablets must be taken once daily for 30 days at the starting dose of 1.5 mg, with a dosing escalation schedule that titrates every 30 days to achieve maintenance dosage.
One major consideration to note is that according to the package insert, patients must take oral Wegovy tablets daily and at least 30 minutes before eating food, drinking beverages, or taking other oral medications. Absorption and effectiveness of the medication is based on taking Wegovy following these instructions. This could potentially lead to adherence and efficacy issues, and therefore should be communicated to patients.
Adverse reactions can include nausea, diarrhea, vomiting, constipation, abdominal pain, abdominal distension, headache, fatigue, dyspepsia (indigestion), dizziness, eructation (burping), hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis (stomach flu), gastroesophageal reflux disease, and nasopharyngitis (common cold).
The new Wegovy oral tablet is expected to be on the market extremely soon, with speculation that the FDA could soon approve additional GLP-1 oral medications. However, initial reports note that there will be little cost difference between these oral tablets and the pre-existing injectables, despite hopes that an oral formulation would bring lower costs and greater access. But there is still potential for utilization to increase as the oral tablet formulation presents a more approachable option for patients versus injectables.
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