AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, announced anticipated 2016 milestones for its product portfolio, including ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso™ (sufentanil sublingual tablet system, 15 mcg). Specifically, AcelRx’s corporate goals in the upcoming year are as follows:
- ARX-04 ER and Postoperative Study Completion. AcelRx has finalized the remaining clinical plans for ARX-04 for the treatment of moderate-to-severe acute pain in a medically supervised setting, following a recent pre-NDA meeting with the FDA. Enrollment in the current open-label study (SAP302) in the emergency room (ER) will be continued, and a new study, known as SAP303, is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe acute pain. SAP303 will focus on enrolling patients older than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. Both studies are expected to be completed in 2016.
- ARX-04 NDA Submission. AcelRx intends to pursue an indication for ARX-04 of moderate-to-severe acute pain in a medically supervised setting. Assuming successful completion of the above studies, the company anticipates submitting the NDA for ARX-04 in the second half of 2016.
- Zalviso Open-Label Phase 3 Study Initiation and Completion. The company continues to advance the regulatory process for Zalviso and has completed a protocol review with the FDA. The Phase 3 study (IAP312) will primarily measure the rate of device errors, including the failure to dispense medication as well as the incidence of misplaced or dropped tablets. AcelRx expects to initiate the study in the first quarter of 2016.
- Zalviso NDA Submission. Pending timely completion of the IAP312 study, AcelRx expects to resubmit the NDA for Zalviso before the end of 2016.
- Zalviso EU Commercial Launch. In September 2015 the European Commission approved Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. The marketing authorization was granted for the 28 EU member states as well as for the European Economic Area countries, Norway,Iceland and Liechtenstein. Grunenthal Group, AcelRx’s licensee in Europe, will be working with the member states of the EU and EEA to ensure that Zalviso is made available to those patients who would benefit from an effective and reliable solution for their acute moderate-to-severe post-surgical pain. The companies expect the product to be available to Western European patients in the first half of 2016.
“Our interactions with the FDA have been productive and have provided guidance for meeting the FDA’srequirements for submitting an NDA for ARX-04 and the resubmission of an NDA for Zalviso,” stated Howie Rosen, interim CEO of AcelRx. “With this clarification on the regulatory pathways, our focus in 2016 will be on execution. Pending positive and timely results from our clinical studies, we anticipate NDA submissions this year for both of our lead products. We also are actively manufacturing supplies to support the launch of Zalviso in Europe by our partner Grunenthal. Should we achieve the milestones that we have laid out for ourselves, 2016 will be a pivotal year for AcelRx.” (Original Source)
Shares of Acelrx Pharmaceuticals closed last Friday at $3.44, up $0.04 or 1.18%. ACRX has a 1-year high of $9.32 and a 1-year low of $2.92. The stock’s 50-day moving average is $4.45 and its 200-day moving average is $4.17.
On the ratings front, AcelRx has been the subject of a number of recent research reports. In a report issued on January 8, Cowen analyst Boris Peaker reiterated a Hold rating on ACRX. Separately, on October 30, Jefferies Co.’s Hugo Ong upgraded the stock to Buy and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Hugo Ong have a total average return of 19.3% and -6.9% respectively. Peaker has a success rate of 44.3% and is ranked #91 out of 3613 analysts, while Ong has a success rate of 0.0% and is ranked #2393.
AcelRx Pharmaceuticals Inc is a specialty pharmaceutical company. The Company is engaged in the development and commercialization of therapies for the treatment of acute pain.