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Arena weight-loss data expected to underwhelm

Arena weight-loss data expected to underwhelm

Upcoming trial results for lorcaserin, the experimental obesity drug being developed by Arena Pharmaceuticals Inc, will likely show it is about 4 percentage points more effective in promoting weight loss than a dummy pill

But that is well short of the 9.4 percent placebo-adjusted weight loss reported last week by Vivus Inc, which is developing Qnexa — a combination of phentermine and epilepsy treatment topiramate, both now sold as generics, that is designed to minimize side effects from the two drugs.

But Wall Street is not discounting the value of a viable treatment for obesity, a health-damaging condition afflicting more than one-quarter of all Americans. “Right now physicians have pretty much nothing,” said JMP Securities analyst Jason Butler.

Piper Jaffray has forecast lorcaserin sales of $3 billion in 2015.

One-year results from Vivus’ Qnexa trials sent the company’s stock up more than 70 percent on Wednesday.

“There is a lot less opportunity for that to happen with this (Arena) trial,” Butler said. “We’ve seen so much data already.”

Shares of Arena, which ended Nasdaq trading at $5.30 on Friday, closed as low as $2.26 in April and as high as $7.42 in February.

The phentermine used in Vivus’ Qnexa is a stimulant that was part of the fen-phen diet drug cocktail. Other drugs used in the cocktail, flenfluramine and dexfenfluramine, were recalled in 1997 after they were linked to heart valve damage.

SIDESTEPS HEART PROBLEMS

Lorcaserin is a serotonin activator like fenfluramine, but it is designed to selectively target only one variety of the chemical — and thereby sidestep heart-related side effects.

Earlier studies have found no heart problems associated with the drug. “There is no reason to expect anything different safety-wise,” from the new trial results expected this month, said Carol Werther, an analyst at Summer Street Research.

The company earlier this year said a large, year-long trial found that lorcaserin patients, on average, lost 5.8 percent of their body weight, while placebo patients lost 2.2 percent of their weight — a percentage point difference of 3.6 percent.

“No single agent has consistently shown a 5 percentage point difference,” said Werther.

U.S. Food and Drug Administration guidelines for obesity drugs require a 5 percent improvement in weight loss between the test drug and placebo or that the number of subjects who lose at least 5 percent of their body weight be at least 35 percent, and double the proportion in the placebo group, with a statistically significant difference between the groups.

The earlier lorcaserin trial found that 48 percent of patients on the drug lost 5 percent or more of their weight, while 20.3 percent of placebo patients achieved that goal

Dominic Behan, chief scientific officer and co-founder of Arena, said a major advantage of lorcaserin is that it is a single agent, and that doctors do not need to adjust doses for patients.

Moreover, he said lorcaserin improved cholesterol levels in patients. And data from earlier trials suggest it can be safely taken on a chronic basis, Behan said. By contrast, he said phentermine is currently approved only for short-term use.

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Fast-acting impotency drug outpaces rivals: study

Fast-acting impotency drug outpaces rivals: study

Biotech firm Vivus unveiled a would-be player Monday in the 3.7-billion-dollar erectile dysfunction market: avanafil, effective in just 15 minutes, far faster than blockbuster rivals Viagra and Cialis.

“The magnitude of success in the first 15 minutes was surprising,” Leland Wilson, the company’s CEO, said in a statement.

Wilson put the spotlight on upbeat results for the class three investigational drug to treat male impotency, now in its last step before it can get a green light from the Food and Drug Administration (FDA).

“This new data further strengthens the profile and differentiation of avanafil from other currently available oral ED therapies,” Wilson said, referring to erectile dysfunction.

While “we knew from the pharmacokinetic profile that avanafil works very quickly, this data is exciting evidence of how fast avanafil really works,” he stressed.

“From our discussions with patients and physicians, we knew that rapid onset was an important attribute in the selection of an ED therapy,” he added.

Knowing avanafil acts in 15 minutes and lasts the length of a sexual encounter should be huge pluses for the drug in this highly lucrative market, said Dr Charles Bowden with Vivus.

The company is eyeing a market launch in early 2012.

Pfizer, which makes Viagra, says its drug acts within 30 minutes to an hour after it is taken. Cialis, made by Eli Lilly, starts working from 30 minutes to six hours after ingestion.

A third competitor, Levitra, acts starting between 25 and 60 minutes after it is taken.

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If you smoke, watch out for low back pain

July 17, 2012Uncategorizedadults, an, and, back, beating, blister, data, diet, Drinking, Drug, eating, Exercise, Flu, for, gallery, Gym, health, Health Health, Health Latest, health video, history, in, laparoscopy, lives, Malaysia Health, medical, of, operation, organic, out, photo, physical, researchers, risk, skin, smoke, smoke Asia, smoke for Weight gallery, smoke for Weight Health photo, smoke Gallery, smoke Health, smoke Health History, smoke Health Information, smoke Health Latest, smoke Health Photo, smoke over Picture, smoke Photo Gallery, smoke Picture, smoke Video, smokes, spiritual, Surgery, symptoms, The, The Finnish, tips, to, training, video, video photo, video surgery, virus, web, web Health, web Health picture, weightlossazuan

If you smoke, watch out for low back pain

If you needed another reason to cut the cigarette habit: Smokers, especially younger smokers, are more likely to report low back pain than people who have never smoked, according to a new analysis.

After examining existing research, Finnish researchers concluded smoking is “modestly” associated with the risk of low back pain and the effects may be “at least partly reversible.” Their findings are published in the January issue of the American Journal of Medicine.

Dr. Rahman Shiri of the Finnish Institute of Occupational Health and colleagues wanted to know if smoking increases the risk of low back pain, a problem that affects an estimated 8 in 10 adults during some point in their lives.

Previous analysis of the existing research came to different conclusions, with one study suggesting an association between smoking and low back pain and the other reporting “unclear findings.”

The Finnish researchers identified and reviewed 81 studies from around the world involving smokers, former smokers, or never-smokers and low back pain conducted between 1966 and 2009. Of those, 40 studies involving more than 300,000 adults and adolescents met the standards for the analysis.

The Finnish team subjected the data of the individual studies to further statistical analysis to tease out the strength of relationships even as the studies reported various outcomes.

They determined that even though the data did not prove smoking leads to low back pain, the analysis of previous the literature suggested a “fairly modest” association between smoking and low back pain.

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