Zogenix加速止痛药Zohydro研发审批进程

Zogenix公司最近宣布公司对于改进其强效止痛药Zohydro已经取得了重要进展。据了解，此次改进主要是为了满足FDA对其要求的防止Zohydro被滥用。公司表示计划在今年十月份向FDA提交胶囊型Zohydro，这种剂型的Zohydro将更难以被成瘾者滥用。公司计划于明年使Zohydro正式上市。然而，这对于Zogenix公司来说还不是高兴的时候。

今年来世界各大制药巨头纷纷进军非成瘾类止痛药药物市场。如Purdue医药公司、梯瓦医药公司、辉瑞公司，他们都在这一领域投入了巨大人力物力。其中梯瓦公司的非成瘾止痛药产品已经取得了足够的数据。因此留给Zogenix公司的时间已经很少了。

详细英文报道：

Zogenix knows it needs to step on the gas. If the company doesn't develop an abuse-resistant version of its controversial-and-powerful painkiller Zohydro--and quickly--another drugmaker will speed past. And that could put Zohydro out of the race completely.

Zogenix recently met with FDA officials to hash out a timeline for new versions of Zohydro, the first all-hydrocodone painkiller. It's now planning to submit a version of the extended-release drug in capsule form in October, aiming to launch early next year. That formulation would be more difficult to abuse by injection or snorting, the company said in a statement. And it's aiming for the first half of 2016 for a filing on a hard-to-abuse tablet.

It's none too soon. Purdue Pharmaceuticals, inventor of the notorious painkiller blockbuster OxyContin, is already hard at work on a hydrocodone-only, abuse-resistant pill. Given that it has already introduced an abuse-deterrent version of OxyContin, Purdue obviously has the technology to pull off a similarly formulated hydrocodone pill.

Meanwhile, Teva has racked up enough Phase III data on an abuse-resistant version of extended-release hydrocodone for an FDA filing later this year. AndPfizer has its own high-powered painkiller on the way, with tamper-resistant features already built in. The drug giant recently touted results of three key studies on that drug, ALO-02.

Aside from the competitive considerations, there's the public relations factor to consider. Since Zohydro won FDA approval last year, Zogenix has been under fire for marketing such a powerful painkiller without tamper-resistant features. After all, the U.S. has experienced an epidemic-level addiction problem, and law enforcement officials across the country have been scrambling to fight back. Massachusetts Gov. Deval Patrick even tried to ban the drug from his state, citing its potential for abuse. And the FDA hasn't gone unscathed, either; lawmakers and activists panned the agency's approval and lobbied for FDA to revoke it.

The FDA has staunchly defended its decision, saying there are plenty of legitimate patients who need a drug like Zohydro to deal with excruciating pain. Zogenix set up an oversight board to help track sale stats to identify any misuse early on.

But the FDA has also said that it's eager to approve abuse-deterrent alternatives to Zohydro if they became available. In fact, the agency's pain drug chief Bob Rappaport has said that FDA would consider pulling Zohydro from the market if those alternatives win approval.