No, it isn't a scientific breakthrough – it is a regulatory breakthrough. Yesterday the FDA approved a new opioid based pain relief medication indicated for use with patients in with cancer who experience breakthrough pain who have developed a level of opioid tolerance. The product is called Onsolis and it is marketed by Biodelivery Sciences International and manufactured by Aveva Drug Delivery Systems. There is even a Webcast about the approval.
The reason it is a breakthrough is that several pain killing treatment candidates have hit a road block when it comes to the FDA. In an environment that is so resolutely focused on risk over benefit – the risk of abuse with these products has expanded to apparently far outweigh the benefits for people, such as in this case, who have cancer and experience severe pain. So the FDA has held off approval of several products, while some manufacturers withdrew plans for others – and people in pain – well, they just had to wait.
The FDA approved the product with a Risk Evaluation Mitigation Strategy (REMS) which has been the reason that other pain relievers targeting the severe pain population have been stymied. Here is what their REMS looks like according to the FDA press release.
Biodelivery will have a program called FOCUS which is considered a "restricted access program" and will require pharmacies, doctors and even patients to register with it before they can be eligible to handle Onsolis. One of the more interesting aspects of this approval is from the financial point of view shedding light on the impact of restrictive REMS programs on the marketing of a new product such as this.
But more importantly, does this approval shed some hopeful light for other pain killing products? Well, only sort of. It is an important aspect of Onsolis that it is to be used only in opioid tolerant individuals – as there is mortal risk posed for those who are not. That is why a program like FOCUS would appear to be tailor-made for this compound – the REMS is very specific to the risk posed by the product, meaning that the program is targeting the product to those who will best understand the risk and the situation.
The American Academy of Pain Management
has a nice overview that demonstrates the extent to which pain is a negative factor not only on individual lives, but on society. The American Pain Foundation
has a chart that demonstrates that pain, as a condition, dwarfs other levels of conditions from which Americans suffer such as diabetes. The statistics reflect millions of people in the U.S. suffering from chronic pain and lacking in adequate pain relief.
"The REMS for Onsolis was specifically tailored for that drug and should not be viewed as a model for long-acting and extended-release opioid products. Developing the comprehensive REMS for these products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and protection." (emphasis added)
Proceeding in a deliberate manner is vague. But one hopes that whatever it means, it means something faster than the FDA has proceeded to date to develop REMS that will allow product approval and bring much needed pain relief to the many, many people who are suffering. For those hoping that the approval of Onsolis signaled that the FDA had finally settled on a REMS for opioid-based extended release products… you will have longer to wait.