A new opioid drug was recently approved by the Food and Drug Administration (FDA), which is considered to be 1000 times more powerful than Morphine and 10 times stronger than Fentanyl. Dsuvia was approved by the FDA as an effective replacement and standard application for IV painkillers as utilized in hospitals.
The drug Dsuvia is a sublingual version of sufentanyl, and is developed for the management of acute pain in a supervised medical setting. The opioid painkiller will be restricted for limited and controlled use mostly only in health care sector such as hospitals, emergency rooms and surgery centers.
On a bright side, Dsuvia possesses a unique ability to provide immediate relief even in extreme pain, without the need of administrating the drug intravenously. It may be useful in difficult healthcare situations such as battlefields. It may also be highly effective in operating room for anesthesia and sedation purposes.
Dsuvia was manufactured by AcelRx Pharmaceuticals in association with Department of Defense with the military medical use in mind. The company says that trauma patients will now have quick access to treatment of high level pain in different care settings.
However, the approval of the drug was highly criticized, and the critics worry the opioid will fuel an already gloomy opioid epidemic. On the same day Dsuvia was approved, Drug Enforcement Administration released a report showing that most overdose deaths of any illicit drugs is caused by prescription drugs.
Democratic Senator Ed Markey of Massachusetts opposed the approval of Dsuvia, saying “an opioid that is a 1000 times more potent than morphine is a 1000 times more prone to abuse, and a 1000 times more prone to cause death.”
The FDA Commissioner has assured ‘very tight restrictions’ will be put on Dsuvia, and has also taken some crucial steps in reducing the risk of abuse. The drug will be available only under strict medical supervision in a single-use disposable form.
Essentially, the FDA has reserved the use of Dsuvia in patients for whom there is no other option for pain treatment available, or where current treatment options have not provided adequate pain relief. The FDA has also issued the highest warning called ‘black box’ indicating serious hazards linked to the drug.
The safety and efficacy of Dsuvia were evaluated in a randomized placebo-controlled trial with 161 patients (between 18 to 69 years) having acute post-operative pain after abdominal surgery. Patients were administered with Dsuvia 30mcg or placebo with a 60-minute gap between doses.
Patients using Dsuvia showed significant improvement in their condition as compared to the patients in the placebo group. Approximately 22% patients using Dsuvia and 65% patients on placebo underwent rescue medication within the initial 12 hours of the treatment process.
While the US is gripped by a serious opioid crisis, it is generally believed that the approval of Dsuvia may not cause a notable escalation of the situation, considering the precautions around it. And its use may be significant in emergency rooms and operation theaters.
And the comparison between Dsuvia and Fentanyl may also be absurd. Many people get high from synthetic opioids like Fentanyl, but just because a drug is 1000 times more potent does not mean the high is also 1000 times more powerful. It simply means the required dosage for the same effect is much less.
Dsuvia will not be accessible from retail pharmacies nor it will be made available for home-use. The opioid drug, which comes in a one-time use applicator, also should not be taken for more than 3 days. The painkiller comes in a tablet form that dissolves under the tongue. Side effects of the potent drug include extreme lethargy, breathing difficulty, coma and even death.