Vivus’s (VVUS), a specialty pharmaceutical company, had faced many setbacks with it’s drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA. In March of 2011, several studies were published demonstrating teratogenicity with one of Qnexa’s main ingredients, topiramate.
Despite this, earlier this year, the FDA accepted Qnexa’s NDA for resubmissions. This was after the company had submitted 2-year extension data, as well as results from FORTRESS, a restrospective study on the incidence of oral clefts associated with maternal topiramate use.
Now, Qnexa’s PDUFA date is quickly approaching, slated for Tuesday July 17th, and it appears that the company is already preparing for approval with regards to branding, marketing and post-marketing activities.
REMS web page
Vivus has prepared a webpage on it’s site that outlines a potential REMS program. This site has the trade name etched out with “TBD” in it’s place. Furthermore the link appears to be a generic placeholder. But the content is notable for the following statement:
VIVUS has worked with the FDA to develop materials to communicate the risk of fetal harm to healthcare providers and patients.
Source: Now, Taken Down by Company – http://www.vivus.com/component/content/article/198-medical-affairs/1007-rems-program
“Q and Me”
According to a source, Vivus will also launch a companion online tool with Qnexa, called “Q and Me.” This is inline with a USPTO trademark filing by Vivus on May 14th, 2012:
Providing a website featuring information and advice in the fields of health, healthcare, diet, weight loss, diet planning and lifestyle wellness, and featuring online tools for management of diet, dieting and weight loss programs
Other Trademarks and Domain Names
Vivus has also trademarked several similar names to QNEXA, including KUNESCA, QNIXERA, QNISA, QVESA, and QNEXPERT, etc. Furthermore it has secured several domains including Qnexa.com and Qnexaandme.com
Adverse Events and Product Complaint Reporting
Vivus has also set up an Adverse Event and Product Complaint Reporting System for both STENDRA and QNEXA, again QNEXA is written as “TBD”
Source: Now, Taken Down by Company – http://qnexa.com/component/content/article/198-medical-affairs/1011-adverse-event-ae-a-product-complaint-reporting
Our take on this, is that it signifies that Vivus’s management has already communicated to it’s web design and marketing teams that it has reached, at least, certain agreements with the FDA. Furthermore, the company has begun to implement post-marketing measures. Does this mean approval is foregone, absolutely not, but it is interesting to note.
For more information on the Qnexa NDA and potential post-marketing issues, please read our Premium Report and Trade Strategy for subscribers only. Also check out our Members Only Forum for more interesting discussions.
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