FDA Approves First Generic for Demser

July 27, 2020 – The U.S. FDA has approved Amneal Pharmaceuticals’ generic version of Demser® (metyrosine – Valeant Pharmaceutical) oral capsules. Metyrosine is indicated for use in patients who have pheochromocytoma to provide preoperative preparation for surgery, management when surgery is contraindicated, and chronic treatment of malignant pheochromocytoma. Amneal’s generic is the first for Demser to be approved in the United States.

A rare type of tumor, pheochromocytoma usually develops on the adrenal glands and leads to excess hormone production. This can lead to signs and symptoms that include high blood pressure, headaches, sweating, a pounding heart, feeling shaky, and appearing extremely pale. Surgical removal is the most common treatment, though some patients may require radiation therapy, chemotherapy, and targeted drug therapy. Although usually benign, pheochromocytoma is malignant in about 10% of cases, meaning it has spread into neighboring tissues or other areas of the body.

Metyrosine works by preventing pheochromocytomas from creating catecholamines, a type of hormone that can raise blood pressure and increase heartrate. Recommended initial dosing is 250mg taken by mouth four times daily for patients 12 years and older. The dose can be increased by 250mg to 500mg daily, to a maximum dose of 4g per day in divided doses. For preoperative preparation, the optimally effective dosage should be taken for at least five to seven days. The optimally effective dose is typically between 2g and 3g per day. Dosage is titrated according to the patient’s individual needs. Use of metyrosine oral capsules in children under the age of 12 has been limited, and a dosage schedule for this age group has not been established under the FDA-approved prescribing information.

Amneal’s generic is available at a wholesale acquisition cost (WAC) of $35,005.39 per 100 capsules, compared to $36,847.78 for the brand.