AcelRx Stopped Cold: FDA Rejects NDA for Pain Drug Dsuvia (ARX-04)

Published: Oct 12, 2017

AcelRx Stopped Cold: FDA Rejects NDA for Pain Drug Dsuvia (ARX-04) October 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff

REDWOOD CITY, Calif. – Shares of AcelRx Pharmaceuticals have plunged more than 60 percent this morning after the U.S. Food and Drug Administration rejected its New Drug Application for the opioid-based pain treatment Dsuvia.

In a Complete Response Letter sent to AcelRx, the FDA said it cannot approve Dsuvia (sufentanil sublingual tablet) without additional data. In a statement issued by AcelRx, the company said the federal regulatory agency said it wanted additional safety data for the maximum dose of the drug from at least 50 patients who participated in the trial. Additionally, the FDA is also recommending changes to the directions for use to “address use-related errors, including dropped tablets, to be validated through a human factors study.”

The FDA has been taking a hard look at opioid-based drugs due to addiction and abuse concerns. In June, the FDA asked Endo Pharmaceuticals to remove its opioid pain medication, reformulated Opana ER, from the market due to abuse concerns. When the FDA made the request, Commissioner Scott Gottlieb said the nation is facing an opioid epidemic, which is forcing the agency to take the “necessary steps to reduce the scope of opioid misuse and abuse.”

The company said the FDA’s requests are something that can be addressed.

"We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings," Vincent Angotti, chief executive officer of AcelRx, said in a statement.

AcelRx filed its NDA based off two open-label Phase III studies that demonstrated a clinically significant drop in pain levels for patients.

As can be expected, investors reacted negatively. Shares plunged from Wednesday’s close of $5.53 to $2.05 this morning.

This is the second time in two years the FDA has kicked back an AcelRx drug due to safety concerns. In 2015, the FDA rejected Zalviso over optical system errors, as well as the shelf life of the painkilling sufentanil tabs the medical device used. Zalviso, is a non-invasive device designed for patients to self-administer sublingual tablets of the opioid sufentanil drug, in an attempt to manage their pain without the use of traditional IV systems.

AcelRx said it intends to request a meeting with the FDA to discuss the topics covered in the CRL, and confirm plans to move towards resubmission of the Dsuvia NDA. AcelRx ended the third quarter with an estimated $67.9 million in cash.
 

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