Another New Opioid On The Market?
The FDA Recently Approved A New Very Powerful Opioid
Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) defended the agency’s approval of a new opioid called Dsuvia, a drug 1,000 times more powerful than morphine. Gottlieb called the drug a welcome addition to hospitals because of its unique nature. In particular, Gottlieb cited the drug’s potential use in the military, for soldiers who cannot have intravenous opioids administered.
This drug is strong – really strong. It is five to ten times stronger than fentanyl, a powerful opioid already on the market. Fentanyl is widely produced and has been responsible for many opioid-related deaths.
AcelRx Pharmaceuticals is the manufacturer of Dsuvia, and the company is not concerned about placing yet another opioid on the market. Dr. Pamela Parker, the company’s chief medical officer, stated that Dsuvia was specifically developed for crisis situations such as acute pain management in a hospital setting. It therefore fills an unmet need, and is supposed to be only administered in managed healthcare settings under the strictest of conditions. Parker stated that AcelRx has placed strict monitoring requirements on manufacturers, distributors and hospitals. The same could be said of most opioids, yet the drugs are widely misused and even abused.
Parker explained in an ABC News interview that current options available to hospitals are not ideal because painkillers only exist in either injectable or oral formulations and take an hour before the patient gets pain relief. Dsuvia is a sublingual (under the tongue) formulation that works immediately. Furthermore, because the dose is sublingual, dosing errors that occur with other forms of medication can be minimized or even prevented.
Other professionals within the FDA do not share the rosy outlook that Gottlieb and Parker have. Dr. Raeford Brown is chairperson of the FDA advisory committee on analgesics and anesthetics. While not present when Dsuvia was “voted in”, Brown has significant concerns about the extremely potent opioid. Brown wonders whether Dsuvia will worsen the already out-of-control opioid crisis, and questions the judgement of releasing the powerful drug into the marketplace – particularly given that 200 million opioid prescriptions are already written each year in America.
Something has got to give to stop the opioid crisis in our nation. There is a tremendous lack of scientific evidence supporting the effectiveness of opioids on chronic pain conditions. There are however, studies showing that opioids don’t work well on chronic pain conditions like low back pain. In fact, opioids have more often been linked to poor self-rated health, disengagement from employment, and a negative influence on quality of life.
Pain medications in general only provide temporary relief, and even the most potent painkillers can’t restore function. H-Wave on the other hand, is an effective drug-free solution for significant pain relief and faster rehabilitation. H-Wave is a viable, non-invasive alternative to opioids for managing chronic, acute and post-operative pain without harmful side effects. The more we examine safe, drug-free alternatives for pain control, the closer we are to making our way out of this opioid crisis.