After repeat attempts to convince the U.S. FDA that the company should not be required to run another clinical trial, it appears AcelRx Pharmaceuticals (ACRX) may have finally hit a wall.
Reported via SEC filing on Tuesday morning, AcelRx said of its latest meeting with regulators, which took place early this month, “FDA reiterated the request to complete a clinical study prior to the resubmission of the Zalviso [New Drug Application].”
Zalviso is an electronic device that dispenses the powerful analgesic sufentanil in a sublingual tablet, meant for the hospital setting as a potential replacement for intravenous morphine. FDA rejected AcelRx’s New Drug Application in July of 2014, requesting additional data demonstrating a reduction in the incidence of optical system errors, changes to address inadvertent dosing with the device, and data to support the shelf life of the sufentanil tabs. AcelRx conducted additional bench testing and ran two Human Factors studies, expecting these would be sufficient to resubmit the NDA. FDA, however, indicated in March of this year that a full clinical trial would be needed to assess the risk of inadvertent dispensing and dispensing failures.
Then, in April, AcelRx requested a Type B meeting with the FDA’s Division of Anesthesia, Analgesia, and Addiction Products. That meeting was denied, and the FDA restated the division’s view that a clinical study would be required. The company persisted in its view that a study should not be required and was finally granted a General Advice meeting with the division for this month to discuss the route to resubmission.
For those keeping score at home: that’s FDA, three, AcelRx, zero.
AcelRx continues to assert that the results of the bench testing and Human Factors studies “adequately demonstrate the modifications made to the Zalviso System to address the items raised in the CRL and that additional clinical studies are not needed.” That’s great, but the FDA simply doesn’t agree. The company insists another trial should not be mandated because its cash and equivalents of $51.2 million won’t be enough to run the trial, resubmit the NDA, and commercialize Zalviso in the U.S. Even with a $15 million milestone payment from European commercial partner Grunenthal for the device’s approval in the EU, which is expected in the fourth quarter, the company will end 2015 with around $45 million, enough for about a year of operations.
Meanwhile, another publicly traded analgesic developer Trevena, Inc (TRVN), demonstrated this month that its own morphine alternative, dubbed TRV-130, was superior to placebo in moderate to severe acute postoperative pain after abdominoplasty surgery. The phase 2b study achieved its primary endpoint of statistically greater pain reduction than placebo over 24 hours, but more importantly, was superior to morphine in pre-specified secondary measures, like reduced nausea, vomiting, and hypoventilation events.
