QNEXA is not Topomax.......described here DRUG DESCRIPTION Topiramate is a sulfamate-substituted monosaccharide. TOPAMAX® (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. TOPAMAX® (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food.
Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethyl sulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solu tion has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-ß-D-fructopyranose sulfamate and has the following structural formula: TOPAMAX® (topiramate) Tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, micro crystalline cellulose, sodium starch glycolate, magnesium stearate, purified water, carnauba wax, hypromellose, titanium dioxide, polyethylene glycol, synthetic iron oxide (25, 50, 100, and 200 mg tablets) and polysorbate 80. TOPAMAX® (topiramate capsules) Sprinkle Capsules contain topiramate coated beads in a hard gelatin capsule. The inactive ingredients are: sugar spheres (sucrose and starch), povidone, cellulose acetate, gelatin, sorbitan monolaurate, sodium lauryl sulfate, titanium dioxide, and black pharmaceutical ink.
Across both studies the most commonly reported side effects were dry mouth, tingling, constipation, altered taste and insomnia. Using tests that followed FDA guidelines, the investigators found no signals for suicide risk. There were no suicide attempts or behaviours, and there was no sign that people were thinking of suicide across all treatment groups, said the company statement.
Overall scores for depression and quality of life, including self esteem and general health showed significant improvement among patients who took Qnexa.
Scores for depression or depressed mood adverse events were similar in Qnexa and placebo groups and under 2 per cent for moderate to severe events.
Leland Wilson, president and chief executive officer of VIVUS said:
"The outstanding results from the EQUIP and CONQUER studies, in addition to the results from EQUATE that were reported late last year, confirm the positive effect of Qnexa and underscore the important role this therapy may play in the lives of patients battling obesity and related co-morbidities, if approved by the FDA."
He said the company plans to file for federal approval by the end of this year and also submit the study reports for peer-reviewed journal publication.
"We believe these results may provide a compelling opportunity for global pharmaceutical companies, and we intend to initiate partnering discussions now that we have the full data set in hand," said Wilson.
However while these results are impressive, according to various reactions in the media this week, there remains the question of what might happen in the longer term, both for patients who continue to use the drug and those who come off it.
In the 1990s the "fen-phen" combination of fenfluramine and phentermine also achieved impressive results with weight loss, but it was eventually withdrawn after reported links with pulmonary hypertension and serious heart valve problems, followed by lawsuits that are still being pursued against the drug maker.
For Qnexa Vivus have combined phentermine with topiramate which is better known as an anti-epilepsy drug although several studies have recently reported it has shown positive results in controlling weight loss and binge eating, according to a comment by Dr Mitchell Roslin, of Lenox Hill Hospital in New York City, reported by MedPage Today.
Source: Vivus Inc, MedPage Today.
Written by: Catharine Paddock, PhD Copyright: Medical News Today Not to be reproduced without permission of Medical News Today
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