Market Overview

PropThink: FDA Confirms Necessity of Ventrus' Second Phase III


By Jake King

As expected, the FDA will require Ventrus Biosciences (NASDAQ: VTUS) to complete a second Phase III study of diltiazem hydrochloride cream (VEN-307) before submitting a New Drug Application (NDA). Diltiazem is a calcium channel blocker often used to treat hypertension, but Ventrus is pursuing a topical formulation for the treatment of chronic anal fissures and associated pain. The second Phase III trial is enrolling and will be completed in the fourth quarter of next year, with a NDA submission to follow before the end of 2013. Ventrus considers the new study a confirmatory measure for previous trial results; VEN-307 met both its primary and secondary endpoints in an earlier Phase III trial, improving pain on defecation and overall related pain. Because the mechanism is already used in cardiovascular indications, VEN-307 is eligible for a 505(b)(2) application, expediting the approval process by relying in part on existing safety or efficacy data. Ventrus has been preparing for a second trial since earlier in the year, so Monday's news is little more than official confirmation from the FDA. The market may react with some negativity regardless, but VTUS should not be under pressure long-term. Read more about Ventrus Biosciences in PropThink's previous coverage.

Read this article in its original form.

About PropThink

PropThink is an intelligence service that delivers long and short trading ideas to investors in the healthcare and life sciences sectors. Our focus is on identifying and analyzing technically-complicated companies and equities that are grossly over or under-valued. We offer daily market coverage, weekly feature stories, and a newsletter to investors who subscribe on PropThink.com. To learn more, follow us on Twitter or visit us at http://www.propthink.com.

Disclaimer:

You should assume that as of the publication date of any report or letter, PropThink, LLC and persons or entities with whom it has relation ships (collectively referred to as "PropThink") has a position in all stocks (and/or options of the stock) covered herein that is consistent with the position set forth in our research report. Following publication of any report or letter, PropThink intends to continue transacting in the securities covered herein, and we may be long, short, or neutral at any time hereafter regardless of our initial recommendation. To the best of our knowledge and belief, all information contained herein is accurate and reliable, and has been obtained from public sources we believe to be accurate and reliable, and not from company insiders or persons who have a relationship with company insiders. PropThink was not compensated to publish this article. Our full disclaimer is available at http://www.propthink.com/disclaimer.







This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.

Source: PropThink via Thomson Reuters ONE

HUG#1655072

 

Around the Web, We're Loving...

Get Benzinga's Newsletters