AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) announced that it has initiated a phase III study, IAP312, on Zalviso (sufentanil, 15mg) for the management of moderate-to-severe acute pain in adult patients in a hospital setting. Shares of the company gained 6.4% on the news.
IAP312 is an open-label study, which will enroll hospitalized post-operative patients (n~315) who will self-administer Zalviso sublingually once every 20 minutes through 24 to 72 hours to manage moderate-to-severe acute pain.
The study is being conducted at the request of the FDA’s Division of Anesthesia, Analgesia and Addiction Products.
Note that in Jul 2014, AcelRx received a Complete Response Letter (CRL) from the FDA in response to its New Drug Application (NDA) for Zalviso. The FDA had asked AcelRx to conduct an additional study on Zalviso to assess the risk of inadvertent dispensing and overall risk of dispensing failures.
Zalviso is currently approved in the EU for the management of acute moderate-to-severe post-operative pain in adult patients.
AcelRx has a collaboration agreement with Grünenthal GmbH for the commercialization of Zalviso in the EU, although it has retained the rights in the U.S. In Apr 2016, Grünenthal had completed the first commercial sale of Zalviso.
Meanwhile, AcelRx continues to progress with another late-stage candidate in its piepline, ARX-04. Earlier this month, the company presented encouraging data from a phase III study (SAP303) on ARX-04 for the management of moderate-to-severe acute pain in post-operative study patients, including elderly patients and those with organ impairment.
AcelRx intends to submit an NDA for ARX-04 for the treatment of moderate-to-severe acute pain in medically supervised settings by 2016 end. We expect investor focus to remain on further updates from AcelRx.
AcelRx currently carries a Zacks Rank #4 (Sell).
Stocks to Consider
A few better-ranked stocks in the health care sector include Ariad Pharmaceuticals Inc. , Anika Therapeutics, Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All of the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ariad has posted a positive earnings surprise twice in the last four quarters, bringing the average beat to 153.54%. The company’s share price has surged 126.5% year to date.
Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 12.6% and 14% over the last 60 days. The company’s earnings have beaten estimates in each of the last four quarters with an average beat of 42.19%. Its share price has jumped 22.1% year to date.
Over the past 60 days, ANI Pharmaceuticals witnessed an increase of 9.5% and 4.7% in its earnings estimates for 2016 and 2017, respectively. The company has posted a positive earnings surprise in two out of the last four quarters, bringing the average beat to 46.85%. The company’s share price has soared 54.9% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>