Fervent Pharmaceuticals Receives Positive Feedback in a Fruitful Pre-IND Meeting With The FDA
Earlier this month, Fervent’s founder and CEO George Royster and his team met with representatives from the US Food & Drug Administration (FDA) for an encouraging pre-IND meeting concerning Fervent’s upcoming vasomotor symptom treatment, FP-101.
An FDA Pre-Investigational New Drug (IND) meeting is invaluable in planning an efficient and successful drug development program. Here, a sponsor can get answers to questions about guidances and other FDA information, as well as identify potential issues that could result in clinical hold issues. Information to assist sponsors in preparing complete investigational new drug applications is also provided.
“The meeting was quite successful, and very informative as well,” Mr. Royster reported. “It was a collaborative dialogue with the FDA, and a number of comments and suggestions that they made will help ensure that next year’s clinical trial is a success. I know I speak for the team when I say that we came away energized and even more optimistic about FP-101 with the positive feedback we received.”
Fervent’s FP-101 is an oral formulation that has been shown in preliminary studies to be effective in treating vasomotor symptoms like hot flashes, night sweats, and insomnia. It’s an existing compound that is non-hormonal/non-herbal/non-antidepressant.
Because FP-101 is an existing drug that is FDA approved for another indication and has a long history of safe use, Mr. Royster determined in the early stages of development that it was the perfect candidate for a 505(b)(2) application. This application pathway allows the sponsor to consult and utilize data not developed in-house, and was created to avoid needless duplication of studies already performed on an approved drug.
Fervent’s decision to pursue this pathway, potentially saving the company both time and capital, was spearheaded by Mr. Royster. “A 505(b)(2) application is always an attractive option when a product fits the prerequisites. If successful, it can save a company millions of dollars and eliminate several years of development time.”
Fervent’s Phase II clinical trial begins in 2017, and will be carried out in a network of clinics across Illinois, North Carolina, South Carolina and Tennessee.