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November 7, 2018

FDA Approves Controversial Drug In Face Of Opioid Crisis

by XPS Staff 

Although the U.S. is fighting an ongoing opioid crisis, a new opioid medication that’s up to 10 times more potent than fentanyl was approved by the U.S. Food and Drug Administration. 

AcelRx Pharmaceuticals Inc. developed the drug Dsuvia, which is a tablet that comes in a pre-filled, single dose applicator. Patients are only given the drug by healthcare providers in emergency rooms, surgical centers and hospitals. 

Dr. Scott Gottlieb, FDA commissioner, swiftly defended the decision by saying the agency was trying something new to deal with the ongoing crisis while still paying attention to the patients’ needs and the doctors managing their pain. 

Gottlieb spoke with Dr. Sanjay Gupta, CNN’s chief medical correspondent, in April and said the nation’s biggest issue is the opioid crisis and its over-prescription of the drug. He said more people in the U.S. die from drug overdoses than breast cancer. 

After Dsuvia’s approval, he said opioids are a unique type of medication, and he understands the debate about the class. Gottlieb said the agency is taking action to reduce the risks and maintain the benefits they provide.  He said he understands people’s concern about Dsuvia’s approval and the need for yet another powerful opioid when the nation is facing a huge addiction problem.

Public Citizen, a public advocacy group, was quick to criticize the agency’s action saying the FDA was being reckless and endangering people’s lives with its approval. It said Dsuvia is about 10 times stronger than fentanyl and 1,000 times stronger than morphine.

AcelRx said Dsuvia is only available to doctors and other care professionals in a healthcare environment – not in retail pharmacies or outpatient use. Only certified and authorized representatives of the Dsuvia Risk Evaluation and Mitigation Strategy program will be allowed to dispense the drug. The company said it’s only to be given to individuals who cannot tolerate other forms of pain treatment or when existing pain treatment methods failed or cannot be tolerated. 

According to AxelRx, the drug would most benefit soldiers who have been injured during battle. The company said the Department of Defense helped with the development of Dsuvia, and the Pentagon deemed it a priority. 

An FDA advisory committed denied Dsuvia in 2017 because there wasn’t enough data to support an approval. The company came back to the agency, which approved the drug on Oct. 12.  Dsuvia is set to enter the market during the first quarter of 2019.

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