Impax Laboratories, Inc. announced this week that the United States Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets.
EMVERM is indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections. Pinworm is a highly contagious parasite that infects approximately 40 million people in the United States each year. Pinworm infection is three times more common than head lice. EMVERM is not for persons who have shown hypersensitivity to the drug.
“We are pleased to announce the approval of EMVERM, a new prescription product for the treatment of pinworm and certain worm infections,” said Fred Wilkinson, President and Chief Executive Officer of Impax. “EMVERM is an important treatment option for pinworm as it offers a 95% clinical cure rate in a single 100 mg dose. We currently expect to initiate commercial distribution of EMVERM early in the second quarter of 2016.”
“As part of our life cycle plan to enhance our anthelmintic franchise in addition to ALBENZA® (albendazole), with this approval, we can now offer an anthelmintic to treat the most common worm infections in the United States. Additionally, the approval of ENVERM further leverages the strategic benefits of the Tower Holdings acquisition,” Mr. Wilkinson concluded.
ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. ALBENZA is also indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. ALBENZA is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of ALBENZA.