2015年3月10日讯 /生物谷BIOON/--当去年夏天，AcelRx公司开发的新型止痛药物/器械系统被FDA否决时，分析人士一直抱有希望认为这种产品将很会重回FDA管理者的办公桌前。尽管这一挫折导致AcelRx公司股价暴跌30%，许多人都相信AcelRx公司最终会上演一出王者归来的好戏。然而，本周AcelRx公司透露FDA要求公司再次补充提交Zalviso相关新数据时，这一幻想被彻底打破了。
根据FDA的最新要求，AcelRx公司必须向FDA提交关于Zalviso工作误差数据方面以及能够证明其正常工作寿命相关数据的研究。这就意味着公司必须就Zalviso开展新的研究以满足FDA对Zalviso的刨根问底。FDA的这一决定无疑宣告AcelRx公司今年将无望重新提交Zalviso。这一消息也使得公司的股价再次重挫40%之多。同时，外界也疑惑为何FDA会在否决Zalviso申请的八个月之后才再次对这一药物提出新的审批要求？
Zalviso作为一种新型的止痛药输送系统，一直被AcelRx公司给予厚望。这种系统是一种舌下微型药片设备，该设备能够自动向患者体内输送阿片类止痛药物，大大降低了患者自己注射止痛药物的危险和繁琐程度。AcelRx公司希望这一产品能够取代目前在医院中广泛使用的IV系统。
事实上，这一系统也收到了各方的关注。去年秋天，德国的Grunenthal公司就和AcelRx公司达成协议，当该产品获得欧洲和澳大利亚医药管理部门的上市批准时，Grunenthal公司将向AcelRx公司支付2亿2千万美元的里程碑奖金。不过，如今看来，AcelRx公司的前路仍然困难重重。
详细英文报道：
When the FDA rejected AcelRx's drug/device Zalviso for pain last summer, the biotech said no new trials were required--suggesting it could be back in front of regulators quickly--and investors responded with a swift punch to the gut, cutting the value of shares by more than 30%. This morning the biotech amended that by saying a new study is needed after all, and investors responded with a punch in the face, sending shares down by more than 40%.
Even last July the Redwood City, CA-based biotech's position with the FDA was more than a little murky. According to AcelRx ($ACRX), the FDA wants to see more bench data related to errors using the system, changes in operating instructions and "additional data to support the shelf life of the product." Some of that additional info may have already been filed with the FDA, according to the Redwood City, CA-based company, but some added work would be needed as well.
It came as more than a bit of a nasty surprise that now, in addition to the work done over the past 8 months, "an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures."
As a result of the setback, the biotech says it will not be filing a complete response to the FDA this quarter. Instead it plans to follow up with new talks with regulators to clarify what needs to be done, and no substitute timeline was offered.
AcelRx started today with a market cap of about $382 million. Its CEO, Richard King, announced he would step down last November in the aftermath of the first setback. As of today, though, he's still CEO.
Zalviso is being billed as an easier and safer method for allowing hospital patients to self-dose using a sublingual microtablet of the opioid sufentanil, replacing IV systems now in use. The system would be marketed as an improvement over IV methods now used in hospitals
Germany's Grunenthal paid $30 million upfront and promised up to $220 million more last fall as it licensed European and Australian rights to the pain therapy.