Despite warnings of likely abuse, the FDA has recently approved a new form of an extremely potent opioid – Dsuvia – a fast-acting alternative to IV painkillers. Dsuvia is a tablet form of sufentanil, which has been used since 1980s. The critics, however, point that Dsuvia “is 10 times stronger than fentanyl a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years.” See the New York Times report (11/2, A12, Goodnough).
Many consumer groups and advocates expressed well-reasoned concerns that the drug is likely to be diverted, abused, and possibly cause deaths due to its potency.
The FDA responded with a statement emphasizing that the drug is delivered through a “pre-filled, single-dose applicator” and is limited to hospitals, surgical centers and similar settings. The drug cannot be dispensed for self-use and will not be available at retail pharmacies.
Interestingly, Dsuvia’s testing and development was sponsored by the Department of Defense as a potential pain relief to injured soldiers who might not have access to IV painkillers.
Addressing diversion concerns, Dr. Gottlieb – the FDA commissioner – also explained the FDA’s powers to require post-market studies evaluating the efficacy of opioid medications. Using such powers, the FDA requested last year that the manufacturer of Opana ER (another potent opioid) take the product off the market due to potential abuse.
AcelRx, Dsuvia’s manufacturer, made an official statement that the company will strictly follow REMS guidance (a safety program for certain potent medications), such as monitor distribution and audit wholesalers’ data, perform drug’s DURs, and flag any indications of any diversion or abuse.
Many public health advocates met this statement with criticism, pointing that the drug is so potent that the first unsupervised injection may cause death. Some advocates are attempting to reverse the FDA’s approval on the procedural grounds. See: NPR (11/2, Harper); The AP (11/2, Johnson).
Despite the opposition, the manufacturer intends to start selling the product in early 2019 at a price of $50 to $60 per tiny pill (but which provides the same pain relief as IV morphine).