Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Weezuhl- Xtampza has a food effect issue... That is why it is not commercially successful.

A good point, wimusky, but I'm not sure the food effect has much to do with commercial viability. With Xtampza, the bigger the meal, the bigger the dose. You don't have to take it with food, but you should be consistent in how you take it in order to get consistent results. Not a big deal. But I don't want to let the main point get lost in the weeds of Xtampza pharmacokinetics. Five ADF drugs are currently officially listed in the FDA Orange Book as "Discontinued." When these drugs were developed, and when I started following the ADF's, there was a general assumption that ADF's would be mandated at some point. But that never happened for a variety of reasons, including organized opposition from health insurers and generic drug manufacturers, as well as typically spineless lawmakers. The power usually goes to the biggest campaign contributor, and as usual, the private health insurers and pharmacy benefit managers are left to make the critical decisions on preferred drugs, and their algorithms are based on profit motive and not community well being.


OxyContin is an exception to the poorly performing ADF's. It is a Frankenstein that was built by the mad Sacklers of Purdue and only retro-fitted with an ADF leash after the beast had already raped and pillaged all of Appalachia and most of Florida. It is the only ADF with sales anywhere close to the billions. All the rest of the ADF's are just tens of millions. And, of course, 5 of 10 never left the gate. Think about how many millions of dollars was spent to develop these drugs and take them to the point of FDA approval with a special claim on the label. They've already done all the work, spent all the money, defended at AdCom, and gotten the coveted approval, and despite all this, these companies do not think it is worth it to spend the relatively small amount of money necessary to manufacture and market their drugs. This is how you should understand the current ADF market. Things could change, and those companies may eventually market those drugs. But to say the least, now is not a good time to be needing a partner with deep pockets for a new ADF. There are already five ADF's collecting dust.