Some opioid painkillers used by cancer patients are governed by U.S. Food and Drug Administration plans to manage possible health risks. The FDA is changing how it manages these drugs and these changes should help Raleigh, North Carolina company BioDelivery Sciences International (NASDAQ:BDSI). Here’s how.
BDSI’s product Onsolis delivers the painkiller fentanyl through a small piece of film placed on the inside of the cheek. Other brand-name drugs that have a similar transmucosal drug delivery system include Abstral, Actiq, Fentora and Lazanda. Companies that make these transmucosal immediate release fentanyl products have all been required to have individual programs set up with the FDA to manage both the access to these narcotic drugs and the health risks to the patients.
When Onsolis was approved in 2009, BDSI became the first company offering such a drug to fall under these plans called a Risk Evaluation and Mitigation Strategy, or REMS. Under the REMS, the FDA has guidelines on how a product is made available to patients to limit drug abuse and health risks. For example, Onsolis is currently available only through specialty pharmacies that fill prescriptions by mail. And doctors must sign a registry acknowledging that they’ve read about the drug’s health risks.
The FDA required REMS of the other companies. But those competitors reached the market prior to the creation of the REMS requirement. BDSI’s competitors haven’t exactly been clamoring to adopt requirements that would make it more difficult to sell their drugs. BDSI has stated on multiple occasions that the slow sales growth of Onsolis is due to an unlevel playing field: Onsolis must play under a REMS requirement but competitors do not.
“BDSI was the first company required by the FDA to have a REMS program for a transmucosal fentanyl product,” CEO Mark Sirgo said in a statement. “Unfortunately, companies with similar products being marketed prior to the approval of Onsolis were not all held to the same standard.”
That’s changing. The FDA announced on December 29 that all drug companies whose products provide transmucosal delivery of fentanyl will fall under a single REMS program. Doctors prescribing Onsolis, or any of these other transmucosal fentanyl products, will still need to complete the same paperwork and provide patients. But the entire management program will be standard for all drugs in this class. Sirgo said the changes also open the possibility for Onsolis being made available in retail pharmacies, which would help grow the drug’s sales.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Revenue growth is something BDSI needs. Onsolis is BDSI’s only FDA-approved product. In 2011, the company recognized $2.7 million in Onsolis revenue through the third quarter, up from $1.9 million in the same nine-month period of 2010. While it’s nice that BDSI is seeing revenue growth, the company is capturing a small slice of what is an estimated $375 million market for transmucosal fentanyl products for breakthrough pain.
The single REMS program for transmucosal fentanyl products will start in March. Until then, companies will continue to follow their existing REMS programs. The FDA says the changes will ease the burden on a healthcare system that currently has multiple REMS programs for multiple fentanyl products. A single system will make things easier for doctors, pharmacies, drug distributors and patients. BDSI will be anxious to see whether that single system will also translate into better sales.
