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AcelRx seeks US approval for acute pain drug

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AcelRx seeks US approval for acute pain drug

AcelRx Pharmaceuticals Inc. submitted a new drug application to the U.S. FDA for ARX-04, its drug candidate for the treatment of moderate-to-severe acute pain.

The application is supported by results from the entire ARX-04 clinical program, including data from four trials that showed improvement in pain intensity within 15 to 30 minutes of dosage.

The company is using the application to prepare a marketing authorization application to the European Medicines Agency, with a target submission date in the first half of 2017. The company is also exploring potential European partners for the drug.