November 16, 2012 / 3:50 PM / in 5 years

AcelRx pain treatment as effective as standard care in trial

(Reuters) - AcelRx Pharmaceuticals Inc said its drug-device combination for post-operative pain was at least as effective as the standard of care, suggesting it has the potential to replace the current treatment.

AcelRx plans to file for marketing approval for the device in the third quarter of 2013, Pamela Palmer, co-founder and chief medical officer of AcelRx said on a conference call with analysts.

The company’s stock jumped 42 percent to a year high of $4.55 in heavy volume trade on Thursday, making it the third biggest percentage gainer on the Nasdaq.

AcelRx tested its ARX-01 Sufentanil NanoTab patient-controlled analgesia (PCA) system against intravenous (IV) PCA with morphine on 359 adult patients in a late-stage study.

Initial data from the study also showed that the NanoTab System was significantly better than intravenous morphine.

In terms of the efficacy, ease-of-use and patient satisfaction, it was a great response, Guggenheim Partners analyst Louise Chen said.

”There are other pain drugs out there, but in terms of a drug-device combo like this, I am not currently aware of anything that’s out there or that is as far along as this, Chen said.

The treatment could bring in peak sales of $247 million in 2018. However, if the company’s ARX-01 technology replaces the standard therapy, peak sales could top $3 billion, Chen added.

Intravenous PCAs with morphine are commonly used on patients in hospitals to manage pain after a surgery. However, opioids such as morphine can cause side-effects such as nausea and vomiting, and also carry the risk of causing addiction.

“Given the significant shortcomings of intravenous morphine, we believe with superiority data from a sublingually administered analgesia will go a long way in creating strong demand and usage in the hospital setting,” Cowen & Co analyst Edward Nash wrote in a note.

AcelRx said its NanoTab device, which consists of a handheld system, provides a non-invasive and more mobile way of treating pain. Instead of morphine, the device administers sufentanil, another opioid that has relatively fewer side-effects and is already widely used in labor and cardiac surgeries.

The late-stage study tested ARX-01 Sufentanil NanoTab in patients who underwent major abdominal or orthopedic surgery.

AcelRx is testing the same device with different drugs in three other late-stage studies involving patients that have undergone other types of surgeries.

Analyst Nash said data released on Thursday improves the company’s chances of finding success with the other ongoing late-stage trials as well.

Analyst Chen has a price target of $6 on AcelRx’s stock. Nash has an outperform rating on the stock, while Chen rates it a buy.

(This story has been corrected to remove reference to Cowen analyst Edward Nash’s price target on AcelRx stock as he does not currently have one; also corrects Guggenheim Partners analyst Louise Chen’s price target on AcelRx stock to $6 from $3.20)

Reporting by Zeba Siddiqui in Bangalore; Editing by Roshni Menon

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