- The Food and Drug Administration finally OK'd KemPharma Inc.'s opioid-based painkiller Apadax on Friday, granting an approval after a prior rejection by the agency in June 2016 and an subsequent appeal from the specialty drugmaker of a Complete Response Letter.
- A combination of benzhydrocodone and acetaminophen, Apadaz was approved for the treatment of acute pain where an opioid is required but no alternatives are adequate. The drug is only meant for short-term use — less than 14 days at a time.
- The Drug Enforcement Administration has indicated it will likely schedule Apadaz as a C-II product, or a drug that has high potential for abuse and is considered dangerous.
Apadaz is a prodrug form of hydrocodone, which KemPharm says is an inert form of the opioid that is cleaved in the GI tract and only then made active.
Despite these claims, which are reflected in the data on the prescribing insert, the FDA did not include in the label that the drug is abuse deterrent, an indication that KemPharm was seeking.
Both the lack of an abuse-deterrence claim and the C-II scheduling from the DEA put major roadblocks ahead for the company. The approval was given over the backdrop of an ongoing opioid epidemic in the U.S.
According to the Centers for Disease Control and Prevention, opioid overdoses killed more than 42,000 in the country in 2016, more than any other year on record. The CDC says that nearly 40% of these overdose deaths were caused by prescription painkillers.
Despite the roadblocks, KemPharm is hoping to differentiate its product once it hits the market. The company said it will pursue pricing similar to generic versions and that it hopes to gain favorable partnerships or contracts with pharmacy benefit managers (PBMs). KemPharm is also exploring contracts with generic manufacturers to distribute Apadaz.
Also, the drug will come in a blister pack that will make tracking abuse easier.
"Although these label features are nuanced … we do believe that this product should be perceived as differentiated," wrote Cowen analyst Ken Cacciatore, who believes the drug could bring in enough sales to help ease financial constraints on the company while it moves other products in its pipeline forward.
"As for the potential commercial opportunity, we would note that given there are roughly 4.8MM annual immediate-release hydrocodone/APAP pills prescribed every year in the U.S. — even when we assume essentially parity pricing with generics at 20-30 cents per pill and utilize only a 20% capture of the market — this would yield a product with annual revenues of roughly $150MM," he wrote.
KemPharma had $55.6 million in cash and securities at the end of the third quarter.
The company is also developing an attention deficit hyperactivity disorder prodrug that it hopes to file by the end of 2018.