Read the rest of this entry ... (216 words left)
Read the rest of this entry ... (216 words left)
Read the rest of this entry ... (216 words left)
The Vernalis drug, like Acomplia, is a CB-1 receptor antagonist that acts by targeting the CB-1 receptor in the brain and suppressing a person's appetite. Vernalis said its drug produced weight-loss results that compared "very favorably" with results for rimonabant.
Average weight loss after 16 days was 1 pound for the overweight and mildly obese patients given a placebo, 6 pounds for those on a 5 mg dose of V24343 and 11 pounds for those on a 100 mg dose.
But Vernalis said results for V24343 from its early trial showed "a markedly reduced propensity for neurological adverse events" and "a lower propensity to induce nausea and GI disturbance."
While Acomplia has been approved and is on sale in Europe, developer Sanofi-Aventis pulled back its application in the United States after it was unanimously thumbed down by an FDA advisory committee concerned over side-effects that included suicidal thoughts and behavior.
Vernalis said the concerns over "risks associated with depression, may be relevant to this class of drug. However, the question as to whether or not other CB-1 antagonists can achieve similar or improved efficacy without major side effects remains open."
Pharmaceutical giants Merck and Pfizer are far ahead of Vernalis in exploring this, with drugs that target the CB-1 receptor already in large phase III trials.
Vernalis CEO Simon Sturge, nevertheless, said his company was "very excited by these preliminary results which, if confirmed over longer studies, will be of significant benefit to overweight and obese patients.
"We stated from the outset of this trial that it is our intention to seek a partner for this program, a process which is enhanced by such promising data," he added.
Read the rest of this entry ... (15 words left)
Anecdotal reports from participants in the Phase III trial of taranabant, otherwise known as MK-0364 or L-000899055, continue to be encouraging, and Merck has said it expects to file for approval to market the diet drug in the United States in spring 2008.
But there have been no presentations of interim results of the trial to scientific meetings and Merck has had little to say about taranabant.
Some suggest Merck has drawn some important conclusions about how-not-to-gratuitously-alienate-the-FDA from recent experiences of Sanof, which trumpeted one exciting result after another from clinical trials of rimonabant only to find things moving slower and slower at the regulatory agency.
With millions of Americans eagerly anticipating approval of rimonabant, the FDA repeatedly delayed action, and Sanofi finally pulled back its application in June -- ending hopes of early approval -- after an FDA advisory panel recommended the diet drug not be marketed until safety issues are resolved.
Meanwhile, taranabant -- which started out several years behind rimonabant -- moves quietly through the clinical trial process. The Phase III trial, which began enrolling participants in fall 2005, will be drawing to an end in the final quarter of this year, with contracts for researchers ending in early 2008.
Final results from this trial, where participants were rerandomized for the second year in an effort to determine what dose is needed to keep off weight lost in the first, are not expected until spring, and there has been no hint Merck will bring interim news to the Obesity Society annual meeting in October.
At a preconference session on New Developments in Obesity Pharmacotherapy on Oct. 20th, researchers plan to report on Qnexa, Excalia, Contrave and Lorcaserin -- but no presentation has been scheduled on taranabant.
While Merck may yet decide to provide some information on interim trial results at any time, the approach on taranabant -- which may wind up being a more exciting diet aid than rimonabant -- has thus far been extremely low key.
Read the rest of this entry ... (12 words left)
| S | M | T | W | T | F | S |
|---|---|---|---|---|---|---|
| « Aug | Oct » | |||||
| 1 | ||||||
| 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| 9 | 10 | 11 | 12 | 13 | 14 | 15 |
| 16 | 17 | 18 | 19 | 20 | 21 | 22 |
| 23 | 24 | 25 | 26 | 27 | 28 | 29 |
| 30 | ||||||
