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AcelRx's Dsuvia Gets FDA Committee Approval, Shares Rally

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AcelRx's Dsuvia Gets FDA Committee Approval, Shares Rally

AcelRx (ACRX) earns majority votes from an FDA advisory committee, which recommends approval of Dsuvia for treating moderate-to-severe acute pain in adult patients.

AcelRx Pharmaceuticals, Inc. ACRX announced that the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has voted (10-3) in favor of Dsuvia, recommending an approval for it. The company is looking to get Dsuvia tablets (30 mcg) approved for treating moderate-to-severe acute pain in medically supervised settings for adult patients.

Although the FDA is not bound by the Advisory Committee's acknowledgement, it will still contemplate its positive recommendation while taking a decision. The FDA has set an action date of Nov 3, 2018.

Shares of the AcelRx were up more than 10% following this news on Friday. In fact, the stock has skyrocketed 96.6% so far this year against the industry’s decline of 4%.
 


 

The safety and efficacy data for Dsuvia was taken from two randomized, placebo-controlled studies with (n=261) patients and two open-label, single-arm studies with (n=216) patients. Data from both the studies showed that Dsuvia was well-tolerated and achieved desirable results in patients of different ages and body mass index (BMIs) as a non-invasive analgesic treatment option for managing moderate-to-severe acute pain.

Dsuvia is a sufentanil sublingual tablet and comes as a pre-filled applicator, intended to treat pain in multiple settings such as injury, ambulatory surgery or to post-operative patients.

We remind investors that in October 2017, the FDA issued a complete response letter (“CRL”) to Dsuvia for the same indication. However, this May, AcelRx resubmitted its new drug application ("NDA") for Dsuvia and the regulatory body accepted the NDA in the same month.

In June 2018, the European Commission granted a marketing approval to Dsuvia (known as Dzuveo outside the United States) for a similar inidication.

Zalviso (15 mcg) is another product of AcelRx, approved in Europe and is in late stage development in the United States.

Zacks Rank & Stocks to Consider

AcelRx currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Caladrius Biosciences, Inc. CLBS, United Therapeutics Corporation UTHR and Genmab A/S GNMSF, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Caladrius’ loss per share estimates has narrowed 5.7% for 2018 and 1.6% for 2019 over the past 60 days. The stock has surged 41.3% year to date.

United Therapeutics’ earnings estimates have been revised 3.6% upward for 2018 and 2.3% for 2019 over the past 60 days.

Genmab’s earnings estimates have moved 1.8% north for 2018 and 11.8% for 2019 over the past 60 days.

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