Repros Therapeutics Inc. (RPRX) announced that it has submitted a complete response to the guidance provided by the FDA last month regarding the expected new drug application (NDA) submission for Androxal (read more: Repros Soars on Positive FDA Meeting Regarding Androxa).
Shares of the company gained 6.7% after the announcement.
Repros is looking to get the candidate approved for the treatment of low testosterone due to secondary hypogonadism. The company further stated that after its follow-up discussion with the FDA for the Environmental Assessment requirements for the NDA, the regulatory body pointed out that performing the appropriate non-clinical experiments during the NDA review period will be considered sufficient for the filing. Additionally, the company believes that it does not have any refuse-to-file issues for its NDA.
Repros expects to file for Androxal by the end of the first quarter 2015 after having all documents ready for the contract organization assisting with the electronic filing of the NDA.
The company expects to submit regulatory application in the EU in the first quarter of 2016. The company is seeking New Chemical Entity status for the product.
AbbVie Inc.'s (ABBV) AndroGel is one of the currently available treatments for hypogonadism in the market.
In a separate release, Repros announced the initiation of two phase IIb studies on Proellex for the treatment of uterine fibroids in women who experience heavy vaginal bleeding as a result of these benign tumors. These studies will be testing two different routes of administration of Proellex, oral and vaginal.
The main efficacy endpoint of both these studies is amenorrhea as recommended by the FDA. Both the studies will have three double-blind arms of placebo and Proellex 6 mg and Proellex 12 mg doses. The company will also evaluate the incidence of amenorrhea, actual menstrual blood loss (to be estimated by the alkaline hematin method from used sanitary products), in the studies.
Patients in the study will be treated by two 4-month dosing courses which will be separated by an off drug interval to allow for menses. The FDA has asked Repros to follow the women for six additional menstrual events to investigate the duration of benefit after the second course of dosing.
Repros intends to request a Type C meeting with the FDA, expected around the end of 2015, after all women have experienced the menstrual event after the first course of treatment. The company will discuss the overall FDA proposed size of the safety database required for an NDA in the Type C meeting.
Earlier phase II studies on Proellex showed that both the oral and vaginal administration stopped menses.
Our Take
We are encouraged by the recent announcements, particularly its update on Androxal. The successful development and commercialization of Androxal is essential for Repros as it has no approved product in its portfolio yet. We expect investor focus to stay on future updates on Androxal.
Repros carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care space include AMAG Pharmaceuticals, Inc. (AMAG) and The Medicines Company (MDCO). Both carry a Zacks Rank #1 (Strong Buy).
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