来自ROMEG Therapeutics 的GLOPERBA® （秋水仙碱口服溶液）（ 0.6 mg/5 mL ）在2019年1月30日获得美国FDA批准上市，这是首款在美获批的治疗急性痛风（ prophylaxis of gout flares ）的口服溶液。

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这款改良新药（NDA 210942）（制剂专利2036年11月到期）：可按需要，调整不同的口服剂量，满足了一些患者（如吞咽困难患者）的需求，2019年夏天将在美国发售。国内截止目前未有秋水仙碱口服溶液获批。

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更多痛风药物信息，查看先前药融数据发表的：

【重药】痛风/高尿酸血症药物研发进展；除此之外，国内在做痛风或者高尿酸血症的有长春金赛刚进入一期临床的金纳单抗台湾安成AC201双醋瑞因、新元素、KBP等。

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附ROMEG Therapeutics 新闻稿：

ROMEG Therapeutics announced the U.S. Food and Drug Administration (FDA) approved GLOPERBA (colchicine) Oral Solution, 0.6 mg/5 mL for prophylaxis of gout flares in adults. GLOPERBA is the first liquid formulation of colchicine approved by the FDA for the prophylaxis of gout flares.

“GLOPERBA represents an important advancement for patients who are experiencing the recurring, painful effects of gout,” said Naomi Vishnupad, Ph.D., Chief Scientific Officer of ROMEG Therapeutics. “Existing therapies do not adequately address the physician’s need to adjust dosages of colchicine to manage the toxicity profile for patients with renal and liver impairments, side effects, common drug-to-drug interactions, and age-related health disorders. The approval of GLOPERBA addresses a significant unmet and underserved medical need.”

Gout is a form of arthritis affecting an estimated 8.7 million people in the United States. The current U.S. market for colchicine products is approximately $800 million. The disease is caused by elevated levels of uric acid in the bloodstream, and symptoms from the buildup of uric acid crystals in the joints include sudden, severe attacks of pain, swelling and redness, frequently at the base of the big toe. Gout can become chronic if left untreated.

Physicians have used colchicine to treat gout for decades, but they are often required to adjust the dose or interrupt treatment to address drug interactions or health conditions such as when patients are undergoing kidney dialysis. Compared with currently available capsule and tablet formulations of colchicine, the GLOPERBA oral solution allows physicians to easily make dosage adjustments for their patients. GLOPERBA is also beneficial for patients who cannot swallow solid doses or pills. About 15 percent of elderly patients have difficulty swallowing and therefore require liquid formulations.

GLOPERBA will be available at chain, independent and specialty pharmacies, long-term care facilities, and hospitals across the U.S. in summer 2019. 

参考：

NMPA/CDE；

药融数据，Pharnex  Datamonitor;

FDA/EMA；

相关公司公开披露；

www.romegrx.com；

等等。