FDA批准首个治疗Low T鼻用凝胶药物

[导读] FDA在5月28日批准了由加拿大生物技术公司Trimel Pharmaceuticals开发的用于治疗男性性腺功能低下症药物Natesto。这也是首个获得批准的利用呼吸道作为给药途径的治疗此类疾病的药物。

2014年6月4日讯 /生物谷BIOON/ --FDA在5月28日批准了由加拿大生物技术公司Trimel Pharmaceuticals开发的用于治疗男性性腺功能低下症药物Natesto。这也是首个获得批准的利用呼吸道作为给药途径的治疗此类疾病的药物。而对Trimel Pharmaceuticals来说，这一批准更显得弥足珍贵，因为今年年初，公司资金仅剩下1800万美元。公司CEO Tom Rossi表示，Natesto为患有男性性腺功能低下症的患者提供了一个更安全，更快速的给药手段，保证能在短时间内提高患者睾酮水平。

一直以来，睾酮都是治疗男性性腺功能低下症的主要药物，然而有研究表明过多摄入这一药物可能导致患者患上心脏病等疾病。因此，FDA在批准这一产品时也着重提醒了这一潜在风险。不过分析人士认为Natesto的获批仍足以挽救Trimel Pharmaceuticals，因为它向外界展示了公司所使用的鼻交凝胶载药系统的前景。（来源：生物谷Bioon.com）

详细英文报道：

FDA's May 28 approval of Natesto, the first nasally delivered testosterone gel for hypogonadism, came just in time for Canada's Trimel Pharmaceuticals, which had just $18 million left on hand at the beginning of the year.

"Men suffering from 'Low T' will now have a different option to raise their testosterone levels. This novel route of administration will enable men to take this therapy in mere seconds, without worrying about the risk associated with transferring the product to women or children. We are now focused on getting Natesto to market as expeditiously as possible so that appropriate patients can have access to it," CEO Tom Rossi said in a statement.

Testosterone treatments remain in potentially treacherous heart health territory, however. A Journal of the American Medical Association study found that using testosterone increased the risk of death from heart attack or stroke by 29% in men with or without a history of heart disease.

The FDA has taken notice. It blocked approval of Endo's ($ENDP) testosterone therapy, Aveed, three times due to the risks of castor oil, a part of the formulation that has been linked to blood-vessel blockages in the lungs and other postinjection complications.

In March, the agency finally approved Aveed as an injection given once to begin therapy, once four weeks later, and every 10 weeks after that. Meanwhile, Clarus Therapeutics has submitted an orally delivered therapy for low testosterone to the FDA and should receive approval (or rejection) by November.

Although Natesto carries a warning for "edema with or without congestive heart failure" in patients with preexisting conditions, it could still save Trimel, and by extension its novel delivery mechanism, which could have other applications besides the now $1.5 billion-plus market for Low T treatments (due in part to heavy advertising).

Around the time of the approval, the company revealed that one of three doses of its experimental nasal testosterone gel Tefina significantly increased the average number of orgasms during an 84-day period for the women in the drug arm to 2.3, compared to 1.7 in the placebo arm. Several biotechs have tried to crack the female sexual dysfunction treatment market, but none have succeeded.

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北京-丹丹 发表于 2014-6-15 06:07 AM
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