Blocked and tackled by the FDA, AcelRx spikes on upbeat update on PhIII pain study

After subjecting investors to an embarrassing about-face when it was forced to concede a major setback at the FDA last year, AcelRx managed to garner a spike in its share price ($ACRX) this morning with its positive assessment of interim data from another one of its Phase III pain therapy studies.

The Redwood City, CA-based biotech reports that the 40 patients dosed so far with ARX-04 in the Phase III trial demonstrated a quick, sharp drop in pain scores after turning up at the ER. ARX-04 uses a prefilled applicator to deliver 30-mcg sufentanil tablets sublingually, which is intended to provide fast relief after an injury.

AcelRx achieved a 14% spike in its share price on the news, but the stock is still trading far below its 12-month high. Last spring the biotech was forced to reverse itself and concede that the FDA was indeed requiring a new study of Zalviso before it would reconsider an approval. Company execs had assured investors the year before that the FDA's objections could be dealt with easily, and suffered a sharp erosion of confidence that wasn't helped when the FDA refused to even discuss the matter.

The company announced last month that it is launching another Phase III for Zalviso--its fourth--which will recruit 310 patients.

The biotech reported last fall that ARX-04 had met primary and secondary endpoints in a separate Phase III study last year.

"In addition to its analgesic efficacy, we assessed the cognitive impact of ARX‑04 on patients in this study," noted company co-founder Dr. Pamela Palmer. "We conducted this analysis at the request of the United States Department of Defense, since drug-induced cognitive impairment on the battlefield is a particular concern. Using a well-known cognitive test, the Six-Item Screener, patients demonstrated no change in mean test scores before and after dosing."

- here's the release

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