FDA Commissioner Outlines Reasons Why a Powerful Opioid Pain Treatment Was Approved
Two days after the U.S. Food and Drug Administration approved a powerful new sublingual opioid medication, FDA Commissioner Scott Gottlieb used his Twitter account to defend the approval amid concerns that the medication is susceptible to abuse.
Developed by AcelRx Pharmaceuticals, Dsuvia was approved Friday for the management of acute pain in adults that is severe enough to require an analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers and emergency departments. Dsuvia, which is reportedly 1,000 times more powerful than morphine, is in tablet form and is meant to be used in a medically supervised setting, however, there is significant concern that the drug could be abused by addicts, particularly in the light of the opioid epidemic sweeping the United States.
On Sunday, Gottlieb took to Twitter, as well as posting a blog on the FDA’s website, to outline why the drug was approved in a time when the country is reeling from an opioid crisis that takes the lives of 116 Americans daily, according to the U.S. Department of Health and Human Services.
Despite the abundance of opioid medications on the market, Gottlieb said the FDA should consider the approval of new opioid pain medications that can help fill targeted medical needs. In the case of Dsuvia, Gottlieb said the drug has some unique aspects that fill a void in the market. He said the sublingual form of the drug makes it easy for some patients to take, particularly those who had difficulty swallowing a pill or receiving intravenous treatment. Specifically, he pointed to the potential use of Dsuvia on the battlefield. Gottlieb said the U.S. Department of Defense worked closely with AcelRx to develop the medication with that goal in mind.
“This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee,” Gottlieb said.
While the potency of Dsuvia raises concerns over its potential for abuse, Gottlieb said the FDA set certain guidance on the administration of the drug. Dsuvia is not for home use and should not be used for more than 72 hours. Additionally, Gottlieb said it will only be administered by a certified healthcare provider using a single-dose applicator.
“These are important steps to help prevent abuse, misuse and potential diversion. The drug is also reserved for use in patients for whom alternative pain treatment options have not been tolerated or provided adequate relief; or are not expected to do so,” Gottlieb added.
Friday’s approval of Dsuvia comes one year after the FDA rejected approval of the drug. In October 2017, the FDA issued a Complete Response Letter to AcelRx calling for additional safety data. The regulatory agency wanted additional safety data for the maximum dose of the drug from at least 50 patients who participated in late-stage clinical trials. AcelRx filed its NDA based off two open-label Phase III studies that demonstrated a clinically significant drop in pain levels for patients.
AcelRx Chief Executive Officer Vince Angotti said the features of Dsuvia and the treatment settings are an important step in the management of acute pain. Angotti said the company is committed to the “safe and effective administration” of the newly-approved Dsuvia through the company’s FDA-approved Risk Evaluation and Mitigation Strategies program.
Pamela Palmer, co-founder and chief medical officer of AcelRx, said the approval of Dsuvia is the “culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings.”
AcelRx plans to launch Dsuvia in the first quarter of 2019. Shares of AcelRx jumped more than 15 percent in Friday trading to close at $4.80 per share. The stock is up slightly in pre-market trading.