Kitov saves time and money by filing combo pill through 505(b)(2) pathway

11-Feb-2016 - Last updated on 11-Feb-2016 at 14:45 GMT

The NDA will require less than three years and cost only approximately $12,000,000. (Image: iStock)

Kitov Pharma says filing combo therapy for US FDA review will take less than three years and cost less than $12m thanks to 505(b)(2) pathway.

Kitov Pharma recently released the Phase III trial results for its flagship drug, KIT-302, a combination therapy that addresses both osteoarthritis and hypertension.

The drug met the primary efficacy endpoint in a recent Phase III study and, according to the company, has the potential to address the multi-billion-dollar market for the treatment of osteoarthritis pain and hypertension, as there is currently no single medication on the market that threats both conditions.

KIT-302 combines celecoxib (Celebrex) and amlodipine besylate in a single pill which will help improve patient compliance, Dr. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer, told us.

“Since both the blood pressure lowering drug and the pain reducing drug (the NSAID) are in the same pill, if the patient forgets to take his medication, the pain will return and thereby remind him of the need to take the combination pill,” explained Dr. Waymack.

Results from the Phase III study have documented that there is a “synergistic effect in lowering blood pressure when celecoxib is added to amlodipine.” According to Dr. Waymack, this synergy was achieved without causing any new safety issues.

FDA approval

In order to shortened the time required for obtaining NDA approval from the FDA, Kitov used the 505(b)(2) application process, which allowed it to use data from the original amlodipine and the celecoxib submissions..

As a result, the company was only required to conduct two clinical trials. Additionally, it was not required to conduct any animal studies.

The two required clinical trials will be a bioequivalence study conducted in less than 50 patients, and a Phase III efficacy study that was conducted in only 152 patients for two weeks.

“In total as a result of this process, from the time of the initiation of the development program for KIT-302 until submission of the NDA will require less than three years and cost only approximately $12,000,000,” explained Dr. Waymack.

Kitov and its CRO, Dexcel, have completed manufacturing of the final drug product.

“All that remains for the CMC development is to conduct sequential assays of the final drug product to verify its chemical stability over time,” said Waymack.

Kitov plans to targets an NDA in the second half of 2016 and marketing approval in 2017.