Over the last decade community leaders, doctors and other healthcare professionals work to reverse the suffering from opioid addiction. The staff at Columbus Addiction Center have also worked to reduce the impact of this crisis locally in the Central Ohio region. Over the years there have been some success and new solutions proposed. However, the U.S. Food and Drug Administration (FDA)  recent made an announcement that could complicate the fight again opioid addiction.

In October 2018, an FDA panel gave preliminary approval for a new opioid for pain relief that is 5 to 10 times more potent than the opioid fentanyl. The FDA drug advisory committee in 10 to 3 vote approved the use of this new drug. The drug is known as Sufentanil, but may be marketed under the name Dsuvia.

The panel vote is not the final step of approval, but the FDA regularly follows the committee’s lead. Previously the FDA had halted approval of the drug due to safety concerns. One concern was that patients could experience adverse health effects if they were given the maximum proposed dose. The other concern is that due to the small size of the medication, there is a risk for misplaced pills which could contribute to abuse and accidental exposure.

In order to address these safety concerns, the company (AcelRx Pharmaceuticals, Inc.) reduced the maximum daily dose from 24 to 12 tablets as well as provided new safety data. To address the concern over abuse and accidental exposure, the company modified directions for use and carried out another study. The new results showed that although the rate of opioid-related gastrointestinal adverse effects was generally higher in patients who took the maximum daily dose, the rate of other adverse effects was comparable between higher- and lower-dose groups.

The company stressed that the Dsuvia is not intended for home use. This means that it would not be sold at drugstores even with a prescription. The drug is intended to only be available in hospitals.

The new drug, Dsuvia, is a sublingual pill form of sufentanil, a synthetic opioid that is used for IV and epidural anesthesia. Dsuvia designed for fast relief from acute pain and can start working in as little as 15 minutes. As a drug, it is only meant for use in medically-supervised settings as well as only administered by trained healthcare professionals. As a painkiller, it does not require swallowing which is potentially valuable for patients who have difficulty swallowing pills. The single-dose form could help avoid dosage errors.

However, some committee members still have concerns about AcelRx Pharmaceuticals’ (ACRX) new drug. Members state that there is a danger in allowing an opioid as potent and potentially lethal as this one onto the healthcare market. It should be remembered that in Ohio, over 70 percent of the state’s drug deaths in 2017 were related to illegally-produced fentanyl as well as related drugs like carfentanil. As a powerful synthetic opioid, Fentanyl has been a major driver in Ohio’s overdose death rates.

Critics are worried about the lack of appropriate education for doctors who might prescribe the potent pain medication. The FDA has not always been able to enforce usage controls with federally approved medications. The increased potency of this drug and the ease with which it will be diverted from hospitals raises legitimate concerns.

Critics continue by arguing that this new pain medication does not offer any unique advantages over other numerous and currently available FDA-approved opioid products for treating acute pain.

There is no unmet medical need that needs to be filled. This new drug may, in fact, create an additional risk of serious harm if accidental exposure occurs or it is misused.

For additional information or questions about this topic, contact the staff at Columbus Addiction Center. Our medical practice is located in Columbus, OH in Franklin County. Our phone numbers are (614) 532 – 1782 or (614) 532 – 7299.

Follow us on Twitter:  @CbusMedCenter  #Addictionhelp  #Addictiontreatment

Fentanyl, FDA