News Archives 2010

Qnexa Archived News 2010

December 20th, 2010
Today Vivus filed a European Marketing Authorization Application (MMA) with the European Medicines Agency (EMA) for its obesity drug Qnexa. The EMA is the equivalent of the United States Food and Drug administrations. If all goes well in the European Union, it would be available in potentially 27 European countries by the end of 2011. If approved it could be prescribed for patients with weight related health issues including obesity, type 2 diabetes, hypertension, dyslipidemia, and other weight associated co-morbidities.

December 14th, 2010
In a continued attempt to obtain regulatory approval of Qnexa, Vivus, Inc. Submitted documentation to the FDA regarding its Complete Response Letter that was delivered October 28th of this year. In that letter, the FDA stated that it could not accept Qnexa in its current form or with the current information it had but needed more information with regards to birth defects and cardiovascular issues. A meeting with the Food and Drug Administration has been arranged in later January 2011 to discuss the details of the new documentation.

October 28th, 2010
Vivus Inc received a complete response letter from the FDA regarding Qnexa and was informed that it could not be approved in its present form. The FDA requested a comprehensive assessment of topiramate's and phentermine/topiramate's teratogenic potential, which is the potential for disturbing the growth and development of an embryo or fetus. The FDA also requested further studies be performed on the association of the medication on heart rate elevation which could lead to adverse cardiovascular events. Vivus plans on proceeding to compile information regarding these issues. The CEO of Vivus Inc stated "We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity." Vivus is expected to submit additional information to the FDA within 6 weeks addressing some of these concerns. While the approval of Qnexa is not certain, there is optimism for an eventual approval, perhaps as early as 2011 since the FDA has not asked for new clinical trials.

-As a side note, their stock (symbol VVUS) jumped as much as 37% on optimism Friday October 29th.

September 21st, 2010
Two year long trail results where made known today and it showed that Vivus Inc's weight loss drug sustained weight loss in most patients for two years and no new side effects where found. Qnexa also showed only small effects on ones heart rate, also issues such as sleep disorders and psychiatric problems where less common in the second year of testing. Patients taking the higher dose of Qnexa for the 2nd year lost an average of 11.4%, patients taking the mid dose lose 10.4% and the placebo group lost 2.5%.

July 15th, 2010
Today an FDA advisory board narrowly recommended that the FDA not approve Qnexa. The vote was 6 to 10 against. Although they admit to its effectiveness, there were some potential safety issues that concerned them. These included possible depression, impaired memory and possible birth effects topped the list. This does not mean that the FDA has yet rejected it; The FDA does not always follow recommendations from their advisory groups but most often does. Vivus CEO Leland Wilson expressed disappointment with the vote but said Vivus plans on working with the FDA to address proper labeling and safety questions. The final decision comes October 28th.

July 13th, 2010
According to an initial review, Qnexa was found to be both safe and effective. This was according to an FDA report that was released today. In it there was also mention of "significant" weight loss reported for patients who had taken part in various clinical testing. There where on the other hand concerns that Qnexa may be responsible for particular psychiatric and cardiovascular side effects and has not been tested enough in pregnant women. This was according to US regulators who would look at it in more depth before it would ever make it to the market. During studies, doctors found that some patients that had taken high doses (not specified) of this proposed medication where 4 to 7 times more likely to discontinue the treatment due to depression, anxiety, and sleep interruption.

June 8th, 2010
There where encouraging results released today from a phase 2 study in which Qnexa was used to fight Sleep Apnea. These results where presented at a Associated Professional Sleep Societies meeting (APSS). It has been estimated that Obstructive Sleep Apnea affects upwards of eighteen million people. There have also been health problems linked to hypertension, stroke, diabetes and heart attacks. During this testing, it was reported that patients also experienced considerable weight loss, reduction in blood pressure and reduced sleep apnea occurrences. Overall it was well tolerated but some patients reported side effects like dry mouth and sinus infections.

May 13th, 2010
On May 15th, 2010 Qnexa will be presented at the 3rd World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy) in Prague, Czech Republic. The name of the presentation will be "Weight Loss With Controlled-Release PHEN/TPM Drives Improvement in Comorbidities in Overweight and Obese Subjects."

May 7th, 2010
Information from the American Society of Hypertension's Annual Meeting had encouraging information regarding blood pressure and those patients taking Qnexa. Systolic Blood Pressure fell five to seven mm Hg after 28 weeks of treatment with Qnexa (using 3 randomized testing trials)

The 3 different groups:

phentermine 3.75 mg with topiramate 23 mg - 234 patients
7.5 mg/46 mg - 591 patients
15 mg/92 mg - 1,582 patients

Weight loss resulted from the trials where:
placebo: 1.9%
Low dose: 5.1%
Mid dose: 8%
High dose: 9.9%
(This weight loss was also reported continuous at 56 weeks.)

Blood pressure reduction at 28 weeks was reported at
placebo: 3.06/1.29 mm Hg
Low dose: 5.13/1.64 mm Hg
Mid dose: 6.77/3.05 mm Hg
High dose: 6.51/2.82 mm Hg

Various side effects where reported by some which included dizziness, nausea, dry mouth, fatigue, headache, constipation, back pain, upper respiratory infection, altered taste, bodily tingling and insomnia. For the highest dose patients, approximately 20% had the side effects of dry mouth and bodily tingling.

The percentages of patients that discontinued due to side effects where:
placebo: 8.5%
Low dose: 11.7%
Mid dose: 11.6%
High dose: 17.5%

Heart rate changes where not noticed in the two lower dosage trials or the placebo, but the high dosage group had an average increase of 1.5 beats per minute.

April 28th, 2010
Vivus will be making a presentation called "Once-Daily, Low-Dose, Controlled-Release Phentermine/Topiramate (PHEN/TPM CR) Improves Blood Pressure and Results in Weight Loss in Overweight/Obese Patients Through 28 Weeks." May 1st to 4th at the American Society of Hypertension's Annual Meeting in New York City. Points of interest during this meeting contain facts on how 68% of men and women in the US are overweight/obese which is at epidemic proportions which is having serious problems in society. Obesity is responsible for many health issues such as diabetes, high blood pressure and cardiovascular diseases. Also
"Patients taking this drug were able to lose clinically significant weight, saw clinically significant improvements in blood pressure and were able to sustain these health gains for a year. As such, we believe our study shows that this is a novel treatment that can lead to significant weight reduction in obese/overweight adults and may alleviate common obesity-related comorbidities such as hypertension."

March 26th, 2010
Today news was released that the FDA will have an advisory panel committee to review Qnexa for the treatment of obesity on July 15th, 2010. During this meeting, there will be a vote of the selected members on whether they believe Qnexa should be accepted by the FDA or not. Reasons as to why each member voted will also be discussed.

March 8th, 2010
Vivus Inc filed for 3 supplementary patents today with Qnexa to expand their intellectual property. This was mainly for ways of using Qnexa. These included, protection in weight loss uses, dosages, controlled release formulas, composition as well as methods for Qnexa's use for sleep apnea. "Together with the original Qnexa patent, these new patents provide substantial protection for our Qnexa franchise into at least 2020." Peter Tam, president of VIVUS

March 1st, 2010
Vivus Inc reports today that the FDA has accepted the filing for Qnexa. The FDA target date, when they are expected to have completed their review is October 28th 2010.

Jan 7th, 2010
News released today confirmed that Qnexa had positive effects in reducing obstructive sleep apnea. This was a relatively small study that included 45 overweight men and women between the ages of 30-65. The study also lasted for 28 weeks. It was reported that there was a 69% reduction in sleep apnea.