KemPharm Inc (NASDAQ: KMPH) is working to have the FDA approve its drug called Apadaz. But there is a major hurdle that the company has to overcome before it can launch the drug on the market: labeling.
The management of KemPharm Inc (NASDAQ: KMPH) has held discussions with the FDA to identify and address issues that need to be fixed before Apadaz can be approved. KemPharm recently said in an investor update that it has been able to address most of the issues that the FDA raised in its complete response letter (CRL) to the company regarding Apadaz.
However, the one major issue that is still pending is the issue of labeling of the product as abuse-deterrent. CEO Travis Mickle has said that dialogue with the FDA continues with the aim of identifying the way of labeling of Apadaz. He added that there exist a number of options to the labeling of the product, so what they are trying to do is assess the options to come up with the most optimal one.
It is not clear when KemPharm will settle the issue of Apadaz labeling, but CEO Mickle hinted that they are trying to get things moving fast. Nevertheless, he admitted that the ongoing efforts concerning Apadaz present a near-term challenge for KemPharm.
Boosting attributes of approved drugs
Even in the face of the challenge of getting a pass for Apadaz, the management of KemPharm Inc. (NASDAQ: KMPH) insists that the bigger picture is not lost. It said the company remains firmly committed to discovering and developing prodrugs that help to improve the attributes of approved medicines.
Among other things, KemPharm’s efforts in prodrug research are geared toward improving efficacy, bioavailability and abuse-deterrent of already approved treatments.
The company uses a discovery platform called LAT (Ligand Activated Therapy) to create the prodrugs.
How KemPharm Inc. (NASDAQ: KMPH) fared in 2Q
KemPharm Inc. (NASDAQ: KMPH) posted EPS loss of $0.58, which was better than the consensus estimate. The company finished the quarter with cash and equivalents totaling $102.6 million.