Retrophin Announces FDA Approval of THIOLA? EC (tiopronin) 100mg and 300mg Tablets for the Treatment of Cystinuria

發(fā)布時間： 2019-06-30 閱讀：1043次

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Enteric-coated formulation offers flexible dosing options, including administration with or without food

SAN DIEGO, June 28, 2019 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ: RTRX) today announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA? EC (tiopronin), a new enteric-coated formulation of THIOLA? (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones. THIOLA EC is expected to be available in July 2019.

“The approval of THIOLA EC marks another step in our continued commitment to helping patients with cystinuria manage the threat of recurring cystine stones,” said Eric Dube, Ph.D., chief executive officer of Retrophin. “This new formulation provides patients with the freedom to administer THIOLA EC with or without food, an advancement over the original formulation which has limiting food restrictions, and also provides the potential to reduce the number of tablets necessary to manage cystinuria. We look forward to working with the cystinuria community as we make the new formulation available next month.”

The recommended initial dosage of THIOLA in adult patients is 800 mg per day and in clinical studies the average dose of THIOLA was approximately 1,000 mg, or 10 pills per day. The original formulation of THIOLA 100 mg is recommended to be administered at least one hour before or two hours after meals. THIOLA EC 100 mg and 300 mg tablets are recommended to be administered with or without food.

THIOLA EC tablets were approved through the 505(b)(2) regulatory pathway which allows the FDA to reference previous findings of safety and efficacy for an already-approved product, combined with reviewing findings from further studies of the product.