ACRX批准leaked？# Stock
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1 楼
yahoo那边论坛上一堆人说看到ACRX官网短暂地露出了下面一段文字，随后被修复。
Our first FDA-approved product, the Zalviso (sufentanil) tablet system is
designed to help address certain challenges with IV PCA in patients
following surgery, such as the IV route of delivery and the potential for
programming and delivery errors by the end user. Zalviso contains an opioid
analgesic indicated for the management of moderate-to- severe acute pain in
adult patients in a hospital setting. Zalviso is not intended for outpatient
use or for use in children and is contraindicated in patients with known
hypersensitivity to sufentanil or components of Zalviso. Please see
Important Safety Information for Zalviso, including Boxed Warnings for risk
of respiratory depression and abuse potential, by clicking here, and click
here for the full prescribing information. The Zalviso Phase 3 clinical
program consisted of three trials; two placebo-controlled efficacy and
safety trials and one open-label active comparator trial, in which Zalviso
was compared to IV PCA morphine. Each of the three Phase 3 trials achieved
its primary endpoint. For additional information about Zalviso, please click
here.
Our first FDA-approved product, the Zalviso (sufentanil) tablet system is
designed to help address certain challenges with IV PCA in patients
following surgery, such as the IV route of delivery and the potential for
programming and delivery errors by the end user. Zalviso contains an opioid
analgesic indicated for the management of moderate-to- severe acute pain in
adult patients in a hospital setting. Zalviso is not intended for outpatient
use or for use in children and is contraindicated in patients with known
hypersensitivity to sufentanil or components of Zalviso. Please see
Important Safety Information for Zalviso, including Boxed Warnings for risk
of respiratory depression and abuse potential, by clicking here, and click
here for the full prescribing information. The Zalviso Phase 3 clinical
program consisted of three trials; two placebo-controlled efficacy and
safety trials and one open-label active comparator trial, in which Zalviso
was compared to IV PCA morphine. Each of the three Phase 3 trials achieved
its primary endpoint. For additional information about Zalviso, please click
here.
