FDA staff question superiority of AcelRx's opioid Dsuvia

In documents released Wednesday ahead of an FDA advisory committee meeting scheduled for October 12, reviewers suggested that AcelRx Pharmaceuticals' oral opioid analgesic Dsuvia (sufentanil) appears to provide no advantages relative to currently available treatments. AcelRx is seeking approval of Dsuvia, which is designed to be taken through a pre-filled single-dose applicator, for adults in a medically supervised setting who are suffering from moderate-to-severe acute pain that requires an opioid analgesic and for which there are no suitable alternative treatments.

The FDA reviewers noted that the efficacy of Dsuvia was evaluated in the Phase III SAP301 study involving adults with acute pain after abdominoplasty, open inguinal hernioplasty or laparoscopic abdominal surgery. According to the staff report, the trial "provided evidence" of the drug's effectiveness in treating acute pain as assessed using the time-weighted summed pain intensity difference from baseline over 12 hours. However, the reviewers noted that since Dsuvia "was only compared to placebo in the one completed Phase III clinical study, there are no data available on the efficacy of [the drug] compared to other therapies."

FDA staff also indicated that Dsuvia "appears to have [the] typical safety profile of an opioid agonist," but they highlighted concerns about its small tablet size, which could result in patients misplacing the medication and accidental use by others. The agency had previously cited the possibility of misdosing and lost tablets in a complete response letter issued to AcelRx for its Dsuvia filing in October 2017. 

Commenting on the FDA documents, RBC Capital Markets analyst Randall Stanicky suggested that the language in the review appeared supportive of an approval. "We expect a focus of this Friday's discussion to be the risks associated with dropped tablets, given their sesame-seed size and high-potency opioid contents," Oppenheimer analyst Leland Gershell added.

The drugmaker's resubmission was accepted in May by the FDA, which is expected to issue a final decision on Dsuvia by November 3. Meanwhile, the therapy was approved recently for the treatment of acute moderate-to-severe pain in medically monitored settings in Europe, where it is marketed under the name Dzuveo.

The FDA staff review of Dsuvia comes a day after the agency released documents ahead of an advisory committee meeting for Trevena's experimental opioid Olinvo (oliceridine). In the review, FDA staff suggested that the drug has abuse and overdose potential, as well as the ability to cause physical dependence. 

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