Yes, and it might be worth it.
Yesterday, Daiichi Sankyo announced an incredible $650 million deal with Florida-based Charleston Laboratories for the development and commercialization of a family of fixed dose combination products.
The lead candidate, CL-108, is a fixed dose combination of promethazine, hydrocodone, and acetaminophen. The deal was signed on the back of a completed Phase III trial demonstrating efficacy in both reducing pain and reducing opioid-induced nausea and vomiting (OINV).
On the surface, this just looks like a combination of Vicodin and Phenergan. So why would Daiichi Sankyo commit $650 million for this combination?
1. The combination provides a clinical benefit claim over other hydrocodone/acetaminophen combination products, such as Vicodin, Norco, and others. The messaging will be easy…”It’s Vicodin, but with an extra ingredient so you don’t feel as nauseous when taking it.”
2. If a patient has a history of OINV, the combination saves the patient the issue of swallowing two tablets. Now swallowing a second tablet may not sound like a big deal to most of us. But when there is significant pain and nausea, taking one tablet will be far easier.
3. OINV is a real problem. According to the press release, up to 30% of hydrocodone experience nausea, and 15% experience vomiting. It does a patient no good to take a pain reliever, only to then lose it due to vomiting. This also creates a lot of questions and uncertainties for the patient. Should the patient take another tablet if vomiting occurred? Was enough absorbed to get an effect? What about the problem of trying to get a refill too early because the patient was taking more tablets than prescribed, simply due to the vomiting?
4. This product could capture share from Vicodin (which interestingly has 300 mg acetaminophen, not 325 mg), Norco (which has a 7.5/325 mg dose), and their generics.
…is, “Will this product gain widespread reimbursement support?”
We’ve already seen combinations of pain relievers co-formulated with drug to reduce side effects get kicked off formularies. For example, Duexis, a fixed dose combination of ibuprofen (800 mg) and famotidine (26.6 mg) will be removed from the formularies of both Express Scripts and CVS Caremark.
These PBMs are also removing Vimovo (naproxen 500 mg/esomeprazole 20 mg) from their formularies.
Other novel formulations of established pain relievers, such as Zorvolex (diclofenac) and Tivorbex (indomethacin) are excluded from various formularies.
The key difference with this product will lie in its clinical benefit claim. If payers can be convinced that the combination makes it easier for a nauseous patient to take his/her pain medication, thereby improving compliance, then Daiichi Sankyo have an excellent opportunity to earn share against well-entrenched hydrocodone brands.