Posts Tagged ‘Vivus Inc’

New obesity drug now available

September 18th, 2012

VIVUS Inc. has announced today the availability of Qsymia for the treatment of obesity. (The drug was previously called (Qnexa) Approved by the Food and Drug Administration, studies indicated patients with obesity had an average 10% weight loss when used in conjunction with a lifestyle modification program.

According to the VIVUS press release:

The safety and efficacy of Qsymia were evaluated in two multicenter, phase 3 trials that included more than 3,700 patients:  severely obese patients (the EQUIP study) and overweight or obese patients with at least two weight-related comorbidities, such as hypertension, hypertriglyceridemia, type 2 diabetes or central adiposity (the CONQUER study). The average weight loss in EQUIP was 10.9% on Qsymia 15 mg/92 mg and 1.6% for placebo (ITT-LOCF, p<0.0001). The average weight loss in CONQUER was 9.8% on Qsymia 15 mg/92 mg, 7.8% on Qsymia 7.5 mg/46 mg and 1.2% for placebo (ITT-LOCF, p<0.0001).

The most common adverse reactions for patients treated with Qsymia included tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth.

The Qsymia REMS program is intended to inform prescribers and female patients of reproductive potential about the following: an increased risk of orofacial clefts in infants exposed to Qsymia during the first trimester of pregnancy; the importance of pregnancy prevention for females of reproductive potential receiving Qsymia; and the need to discontinue Qsymia immediately if pregnancy occurs.

For more information about Qsymia, go to www.Qsymia.com.

For full prescribing information go to http://vivus.com/docs/QsymiaPI.pdf.

 

FDA Approves Qnexa

July 18th, 2012

Vivus Inc. announced today that the Food and Drug Administration (FDA) has approved its anti-obesity drug, Qnexa, which has been renamed Qsymiatm .  Qsymiatm is a combination drug, composed of phentermine and topiramate, both of which have been approved by the FDA for years. As we have previously reported, Osymiatm has the most impressive weight loss of any obesity drug. The FDA has recommended patients discontinue the drug if they lose less than 3% of body weight on the mid-dose formulation or less than 5% on the high dose after 12 weeks. They also recommended monitoring of heart rate for people on the drug and that women of child-bearing age have a negative pregnancy test every month while using the drug. A Risk Evaluation and Mitigation System (REMS) plan includes distribution through certified pharmacies, a medication guide and a timetable for assessments.

The Risk Evaluation and Management Strategy information, Medication Guide, Safety Information and Health Provider Training Program can be accessed at: http://www.qsymiarems.com/

 

 

FDA Panel OKs Qnexa

February 23rd, 2012

Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee  voted overwhelmingly, 20-2, in favor of approval of Vivus Inc.’s anti-obesity drug, Qnexa. It was one heck of a surprise.

The morning session included presentations by the company and the FDA staff on the effectiveness of Qnexa and, especially, the safety profile. The safety issues involved the issue of whether additional birth defects, particularly oral clefts, would result from wider administration of topiramate and whether phentermine contained a risk for cardiovascular events. The panel members were clearly wrestling with understanding the data. The company presented a very comprehensive Risk Evaluation and Management System (REMS) plan to reduce exposure to the drug by women of child-bearing potential. During the discussion, committee members and the FDA expressed concern that the REMS program might be too restrictive. They observed that if access were too limited, patients could do what they are doing now – use the two drugs in the generic forms off-label for obesity treatment.

Considering the cardiovascular risks, they were concerned about the relatively weak,  but nevertheless present, sign of increased heart beats per minute and what that meant. This indicated a cardiovascular outcomes trial (like the SCOUT study for Meridia). The issue was whether the study would be done prior to approval or post approval. The key comments were made by Dr. Sanjay Kaul, usually a hawk on the obesity drugs, who opined that having the trial conducted post-approval would not be unreasonable. The effectiveness of the drug, about a 10% weight loss over a year, was the tipping point.

During the public witness part of the meeting, I testified, along with Ted Kyle for the Obesity Society, Denise Bruner for the American Society of Bariatric Physicians, Chris Gallagher for the American Society for Metabolic and Bariatric Surgery and Joe Naglowski for the Obesity Action Coalition. Ever since Qnexa was turned down in July 2010, we had been encouraging each other to testify and hold up the case for recognition of obesity as a disease and requiring additional tolls to fill the ‘treatment gap’ between lifestyle changes and bariatric surgery.

We huddled together as the votes were cast. The discussion among the panel members all day was of the ‘one the one hand on the other hand’ type. We expected a close vote.  So, we nearly fell over at the 20-2 vote in favor of approval. Of course, the FDA has the final word and it does not have to follow the recommendations of the panel. Nevertheless, it seems more likely than not that the FDA will approve.

At the end of day, I felt that the long shadow that the phen-fen debacle has cast over the FDA might be lifting and that the panel may have achieved a higher recognition of the enormous implications of our ever growing obesity epidemic.

Arena Pharmaceuticals and Orexigen Therapeutics  are still in the game with their drugs. While this positive vote, on the one hand may be good news for them, it may also set the effectiveness bar at a height their drugs cannot meet. Time will tell.

Qnexa’s Second At-Bat

February 17th, 2012

Interest is rising as Vivus Inc.’s next date with the Food and Drug Administration draws near. The Endorinologic and Metabolic Drug Advisory Committee meeting on February 22, 2012 will reconsider whether to approve Qnexa, which is a combination of phentermine and topiramate. Both drugs are already approved by the FDA and are available as generics.  The FDA has put out their briefing materials, as well as that from Vivus on their website. Endocrinologic and Metabolic Drugs Advisory Committee > Briefing Information for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

The materials indicate that the Advisory Committee will be debating how to mitigate the exposure by women of childbearing potential to half of the Qnexa compound, topiramate.

Media interest is reflected in a front page story by Andrew Pollack in the New York Times. Diet Treatment, Already in Use, to Get F.D.A. Review – NYTimes.com

Vivus Inc. Announces Date for FDA AdCom; results of birth defect study

December 23rd, 2011

Vivus Inc. has announced that the FDA will hold an   Advisory Committee meeting on February 22, 2012 for review of the obesity treatment, Qnexa. VIVUS, Inc. – VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of ObesityTwo days ago, Vivus Inc. released resulted of the FORTRESS study.  The study looked retrospectively at women delivered infants while taking topiramate, one of the two active drugs in Qnexa. Compared to women who had taken topiramate earlier but not during their current pregnancy, those taking topiramate during pregnancy reported a higher rate of cleft palates in their children (0.29% v. 0.16%) VIVUS, Inc. – VIVUS Reports Topline Findings From FORTRESS An earlier study unrelated to topiramate reported a higher rate of birth defects overall and cleft palate, in particular, in women with obesity compared to women of normal weight.

The company’s current application would limit distribution to men and women beyond child-bearing age.

Study Raises Prospect of Qnexa Approval

December 15th, 2011

A study published December 7, 2011in the American Journal of Clinical Nutrition provides two-year data on the safety and effectiveness of Vivus Inc.’s drug candidate, Qnexa in patients with cardiometabolic disease.

Qnexa is a combination drug composed of phentermine and topiramate. It was tested in two doses among 676 subjects. Changes in weight were -1.8% for placebo, -9.3% for low dose and -10.5% for the high dose. Significantly more subjects at each dose achieved more than 5%, 10%, 15% and 20% weight loss compared to placebo. Subjects on the drug had improved cardiovascular and metabolic metrics and decreased rates of diabetes. The high dose was significantly better in weight loss among the most severely obese subjects. Adverse events were modest and drop-out rates were similar between placebo and drug groups. There were no deaths. There were two pregnancies. One was carried to term. The other resulted in a miscarriage. The infant was born with no observed birth defects which was a concern of the FDA Advisory Committee which reviewed the drug last year.Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study 

The very impressive weight loss and low side effect profile from this two-year study are expected to improve the odds of approval by the FDA. Another Advisory Committee hearing in early 2012 is expected. 

FDA Accepts New Qnexa Petition

November 3rd, 2011

Vivus Inc. announced that the Food and Drug Administration had accepted its New Drug Application for Qnexa™. The FDA expects to have an Advisory Committee hearing in the first quarter of 2012. The proposed labeling includes a contraindication for women of childbearing age. VIVUS, Inc. – FDA Accepts New Drug Application Filing for Qnexa, At the same time, a study was published on Qnexa ™ in 1,267 persons with severe obesity which showed an average weight loss of 14.4% from initial body weight. VIVUS, Inc. – Qnexa® Phase 3 Data Published In Obesity Show 14.4% Average Weight Loss In Severely Obese Patients Completing One Year Of Treatment

Pharma Companies Hang in There

May 15th, 2011

Drug companies battered by the FDA earlier this year are not taking no for an answer. Vivus Inc. is in discussion regarding Qnexa to make it available for men and women who are not of childbearing age.  UPDATE 1-Vivus to submit Qnexa application as limited indication, shares up | Reuters  Arena Pharmaceuticals  is looking at a three month study of breast tumors in rats rather than the 12 month study the FDA wanted.   Arena pushing shorter study of rejected diet pill – SignOnSanDiego.com  while Orexigen is examining cardiac function effects of its drug, Contrave, see Orexigen submits diet-pill test plan to FDA – SignOnSanDiego.com