New atypical going to phase II clinical trials

Schizophrenia.com is reporting that a new Clozapine like drug is entering stage II clinical trials.

ACP-104 is a actually a chemical called N-desmethylclozapine, a major
metabolite of clozapine (trade name Clorazil). Its development, which has been supported in part by the Stanley Medical Research Center, is designed to provide an atypical antipsychotic level of effectiveness with the added potential benefit of enhanced thinking ability, or cognition.

Suicidal behavior linked to obesity drug

During clinical trials, people who took the drug Zimulti were found to have an increase in suicidal thoughts. Follow the CNN story below.

Psychiatric problems “represent the most common and worrisome rimonabant -induced adverse events,” the reviewers said. Twenty-six percent of Zimulti patients reported a psychiatric symptom, compared with 14 percent of placebo patients, they said.

Bristol seeks approval of abilify for adolescents

Bristol-Myers is seeking U.S approval for the antipsychotic medication abilify to be approved for use in adolescents. About 15 percent of antipsychotic sales came from doctors writing prescriptions for uses currently not approved by the FDA, including for adolescents, analysts say. Once the FDA clears a drug for sale, doctors are free to prescribe it for unapproved, “off-label” uses. Drugmakers can’t promote such uses.

Sales of Abilify surged 41 percent last year to $1.3 billion, the biggest increase among antipsychotics, helped by studies showing it caused less weight gain than competing drugs. Sales of Zyprexa grew 3.8 percent to $4.4 billion last year. J&J’s Risperdal generated $4.2 billion, an 18 percent increase.

Antipsychotics link to death in dementia patients

Both newer atypical antipsychotics and older conventional antipsychotics increase the risk of death when used in older adults with dementia. In the study of more than 27,000 people 66 years of age or older with dementia between 1997 and 2002. Atypical antipsychotics increased the risk of death within the first month of use and the risk may last as long as six months into treatment. Conventional antipsychotics were associated with a greater risk of death than atypicals at both one month and six months.

“Physicians shouldn’t be using some of these drugs the way they’re using them,” Schneider said, noting that they may not be carefully monitoring patients while they’re taking the drugs and they may keep them on the medications longer than appropriate.

A race between pharmaceutical companies

The race for pharmaceutical companies to get their atypical antipsychotic is on. Bristol, Lilly and Johnson & Johnson are racing to get the drugs cleared for use in teenagers. The medications include Abilify, Zyprexa and Risperdal. There is alot of money at stake here. Lilly’s Zyprexa generated $4.4 billion in sales last year, and Johnson & Johnson’s Risperdal had sales of $4.2 billion. Sales of Abilify climbed 41 percent to $1.3 billion.

“There’s no gold standard for treating schizophrenia in teens, and the first company to get FDA approval for this will have a bit of an edge in this very crowded market of atypical antipsychotics,” said Les Funtleyder, an analyst at Miller Tabak & Co. in New York, in a telephone interview.

Drugmakers sold more than $15 billion in antipsychotic drugs last year, according to data compiled by Bloomberg.

The full Bloomberg article is here.

200,000 chinese die from drug misuse

About 200,000 people die in China each year from improper use of drugs, Chinese doctors and pharmacists said during a weekend meeting, and they called for greater efforts to educate consumers.

Risperdal popcorn

Over the weekend I found Ed Silverman’s blog, Pharmalot. It is a commentary of the pharmaceutical industry. This morning I enjoyed his post on Risperdal Popcorn.

Seroquel XR

The FDA approved AstraZeneca’s new version of Seroquel.  Seroquel XR, will be used once a day. This extends Seroquels’ patent for another 10 years. Bloomberg is predicting sales to jump 29%, thats $4.4 billion, yes billion dollars.

Seroquel, which was first approved a decade ago, has been used by more than 7 million people worldwide who take the current formulation twice a day. Reaching an effective dose can take up to seven days with the current pills, compared with the new sustained release version, which is effective from day two, according to a recent study.

Pharmacology study

This is an analysis of prescription drug use from 2001 to 2006. The age range studied is from 10 to 19. Nearly 370,000 insured children were included.

        The number of adolescent girls taking drugs for Type 2 diabetes nearly tripled in just five years, while use of chronic medicines for psychotic behavior and insomnia roughly doubled among boys and girls aged 10 to 19, a study shows.
Meanwhile, adolescents’ use of drugs for depression and attention deficit hyperactivity disorder, or ADHD, leveled off or dropped in the last two years, after widespread new warnings about safety concerns.

Drugs’ effects on schizophrenia

Some interesting work out of Duke University.

“Antipsychotic drugs do most of their work in the brain, but they also leave behind in the bloodstream a trail of hundreds of chemicals that may be used in the future to direct better treatment for schizophrenia and other psychiatric conditions, say Duke University Medical Center researchers.”

“Doctors draw blood every day to look at metabolites such glucose and cholesterol and determine whether someone is at risk of diabetes or heart disease,” said lead study investigator Rima Kaddurah-Daouk, Ph.D., an associate professor of biological psychiatry. “With metabolomics, we can look at thousands of metabolites to attain a more finely tuned map of an individual’s overall health and gain information about how an individual is responding to a particular therapy.”