Responses to this thread will include related FDA announcements

CNS/Neurology
ANDRX SUBMITS NDA FOR VALPROATE PRODUCT
Andrx filed a new drug application with the FDA for a valproate product the company wants to market for the treatment of various seizure disorders, prophylaxis of migraine headaches and manic episodes associated with bipolar disorder. The product will compete in the same market as the Depakote family of brand products.

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NDA = New Drug Application

SERTRALINE HCl EFFECTIVE IN ANXIETY TREATMENT
Pfizer's sertraline HCl significantly reduced symptoms of generalized anxiety disorder (GAD) compared to a placebo, a study showed. The study involved 370 participants diagnosed with GAD at 20 investigational sites in Australia, Canada, Denmark, Norway and Sweden. It is the first large, global, multicenter placebo-controlled trial to investigate the safety and efficacy of the drug in treating GAD.

CNS/Neurology
POSITIVE RESULTS REPORTED FOR PHASE III INSOMNIA DRUG TRIAL
Neurocrine Biosciences announced positive results of the company's second Phase III clinical trial of indiplon to treat chronic insomnia. The drug was demonstrated as safe, effective and well-tolerated in 200 adult patients with chronic primary insomnia during a 35-day period. The study showed significant results in sleep initiation with no evidence of side effects the following day.

METADATE CD COMPARABLE TO RITALIN FOR ADHD
Two studies published in The Journal of Applied Research showed that once-daily Metadate CD (methylphenidate HCl, USP) 20-mg extended-release capsules provided a treatment comparable to Ritalin for attention deficit hyperactivity disorder (ADHD). Results showed ADHD symptom control during a nine-hour observation period in children ages six and older.

ARIPIPRAZOLE IMPROVES SYMPTOMS OF BIPOLAR MANIA
Two studies of the drug aripiprazole by the University of Cincinnati medical school showed that patients with bipolar disorder experiencing an acute manic episode showed significant improvement with the drug when compared with haloperidol or a placebo. The studies also showed a much lower rate of adverse events for aripiprazole.

OLANZAPINE AND FLUOXETINE MAY RELIEVE BIPOLAR DEPRESSION
A study by Eli Lilly showed that both olanzapine and olanzapine combined with fluoxetine provided rapid relief from depression in bipolar patients without triggering a manic episode, a potential side effect of antidepressant treatment in bipolar patients. The drugs demonstrated a significantly faster onset of action compared to a placebo.

PROVIGIL IMPROVES ADHD SYMPTOMS IN CHILDREN
Two Phase II studies of Cephalon's Provigil showed that the drug significantly improved symptoms of attention deficit/hyperactivity disorder in children. The drug was well tolerated at different doses

A study has shown that treatment with Johnson & Johnson's (J&J's) antipsychotic drug Risperdal (risperidone) significantly reduces the risk of relapse in individuals experiencing their first episode of schizophrenia. The study followed 535 people with schizophrenia who took between 1-8 mg of risperidone or haloperidol a day for one to four years. Of the three-quarters of patients who went into remission, 42 percent of those on risperidone later relapsed compared with 55 percent for haloperidol, an older, more conventional drug, according to J&J. The findings were presented at the recent 16th Congress of European College of Neuropsychopharmacology.

Source: FDA

Results from a recent study show that the lowest dose of Forest Laboratories' antidepressant Lexapro was equally effective and just as safe as Pfizer's popular Zoloft drug, according to Forest. The company sponsored the eight-week, head-to-head clinical trial of 212 patients ages 18 to 80 with serious depression. Patients daily took either the starting 10-mg dose of Lexapro or Zoloft in strengths of 50 mg to 200 mg that could be adjusted for individual patients. At week eight, the conditions of patients in both groups improved equally, as measured on a common scale of depression symptoms, and both drugs were generally well- tolerated, Forest said.

FDA OKs ABLE LABS APPLICATION FOR ADHD TREATMENT
Able Laboratories announced its abbreviated new drug application to market a generic equivalent of Ovation Pharmaceuticals' Desoxyn tablets in 5-mg strength has been approved by the FDA. Able's methamphetamine HCl tablets (USP 5-mg CII) are indicated for the treatment of attention deficit/hyperactivity disorder and exogenous obesity.

Pain relief drugs called COX inhibitors may reduce the blood pressure-lowering effects of ACE inhibitors, new research suggests. This drug interaction seems to occur even with newer COX inhibitors, such as Celebrex (celecoxib) and Vioxx (rofecoxib), although these agents do not appear to cause kidney problems that can occur with older pain relievers, such as Voltaren, Motrin and Relafen. Researchers examined the effects of Celebrex and Voltaren on blood pressure and kidney function in 25 patients with arthritis and high blood pressure being treated with an ACE inhibitor. At four weeks, Voltaren worsened overall blood pressure control more than Celebrex in patients who were also taking an ACE inhibitor. However, at peak drug levels, Voltaren and Celebrex had similar effects on blood pressure.

King Pharmaceuticals has begun a Phase II clinical trial program for the development of an extended-release formulation of Sonata (zaleplon), a nonbenzodiazepine treatment for insomnia. The trial is designed to select the most effective extended-release formulation of Sonata using Elan's Spheroidal Oral Drug Absorption System as the drug-delivery technology. The goal of the trial is to determine which new formulation is the most efficacious for the purpose of increasing total sleep time and reducing any potential for premature awakenings, while continuing to build on the quick onset profile currently available in the immediate-release formulation of Sonata.

LEXAPRO AS EFFECTIVE AS PAXIL AND WELL TOLERATED FOR TREATING GENERALIZED ANXIETY DISORDER
Forest Laboratories has announced the results of a six-month study demonstrating that Lexapro (escitalopram oxalate) is as effective as Paxil (paroxetine HCl) in patients with generalized anxiety disorder (GAD). Results of the 123-patient study found that, although both Lexapro and Paxil were associated with improvement in anxiety symptoms, three times as many Paxil-treated patients withdrew from the study due to adverse events than did Lexapro patients, and more than twice as many Paxil-treated patients experienced weight gain.

FDA Issues Warning on Antidepressants
Possible Suicide, Severe Depression, Anxiety, Panic Attacks in Children and Adults
http://content.health.msn.com/content/article/84/98068.htm?pagenumber=1
March 22, 2004 -- The FDA is issuing a warning about the possibility of worsening depression or suicidal thoughts in people, particularly children, who take any of 10 popular antidepressants, especially at the beginning of treatment or when the doses are increased or decreased.

The FDA has sent a letter to drug manufacturers requesting labeling changes on these antidepressants -- warning of possible suicide, worsening depression, anxiety, and panic attacks in adults and children.

Antidepressants involved in this warning label request are:

* Prozac (also sold generically as fluoxetine)
* Zoloft
* Paxil
* Luvox
* Celexa
* Lexapro
* Wellbutrin
* Effexor
* Serzone
* Remeron

"We don't know that the drugs are responsible for these behavioral changes, but nonetheless we're telling physicians and families to be aware of this and that if the behaviors do emerge, to get treatment right away," said Russell Katz, a director with the FDA's Center for Drug Evaluation and Research, in a news teleconference today.

The proposed warning label will "include information about behavioral changes that may occur in patients who are prescribed antidepressant drugs," said Katz.

"This applies to adult and pediatric patients and involves the potential for suicidal thinking or suicidal behaviors and warns the physician and family about any behaviors that might emerge that haven't been experienced before," he added.

But the FDA stopped short of recommending people discontinue taking their antidepressants.

"We specifically decided not to tell people not to use these drugs," said Katz. "We don't think that is necessary at this point."

In addition to looking for signs of worsening depression, the following symptoms may also be a sign of a problem:

* Anxiety
* Agitation
* Panic attacks
* Insomnia
* Irritability
* Hostility
* Impulsivity
* Severe restlessness
* Mania in both adults and children being treated with antidepressants for major depression

If these changes appear, treatment should be evaluated, the FDA says. Medications may need to be discontinued when symptoms are severe, begin abruptly, or if they signal a new disorder.

There also is concern for people who have bipolar disorder (manic depression) but don't know it. Antidepressants have the potential for provoking a manic episode in these people, the FDA says. Doctors, patients, and family members should be on the lookout for any symptoms of mania, including feeling extremely happy or very irritable, inflated self-esteem, not needing as much sleep as usual, talking, or being more active than usual.
Reviewing Studies of Children

The FDA has been closely reviewing studies of antidepressants in children for the past year after an initial report on studies of Paxil and other drugs suggested an increased risk of suicidal thoughts in children given antidepressants. No suicides occurred in any of the trials, the FDA reports.

The analysis has involved 25 controlled trials with 4,000 children taking antidepressants, said Katz. "Those reviews are ongoing."

Today's action "arose from an unexpected observation in some studies of an apparent excess of emotionability, a catch-all term ... that includes suicidal [thoughts]," said Robert Temple, MD, the FDA's director of medical policy.

However, closer examination has shown that the accounts are unclear -- whether certain behaviors reported were actual suicide attempts or other self-injurious behavior that was not suicide-related.

"As we've gone into the studies in detail, it's become evident that the terms used were highly varied and [the studies] not very well done," Temple said.

Experts at Columbia University in New York are providing an independent review of the studies, looking carefully at descriptions of these events to determine whether those cases represent suicidal behavior.

"We hope to have a much better idea whether these drugs are effective and whether or not they do cause suicidal symptoms," said Katz.

"There is an ongoing awareness that children are particularly vulnerable, that they need additional protection, and that we make sure that all the protections are in place," said Dianne Murphy, MD, the FDA's director of Pediatric Therapeutics.

SOURCE: FDA.

I think a link to Neurotransmitter.net's drug development page might be appropriate for those who are interested in pharmacology and the latest in drug development.

http://www.neurotransmitter.net/newdrugs.html

Looks like Shire is having good results from a new formulation of Adderall XR for up to 16 hours

http://www.eurekalert.org/pub_releases/2006-10/pn-sid103106.php

Jeff

FDA released new draft guidelines on all ADD meds:

http://www.addforums.com/forums/showthread.php?t=37224

I find it hard to believe that pfizer is going to let the patent on the number one selling drug in the world expire 1 second early. But on the other hand, this opportunity is too big for ranbaxy to pass up. A favorable verdict would give them exclusive right to sell a generic version of the medicine, for a limited period at a price that is well below lipitor's but gives ranbaxy a huge profit margin.

So Ranbaxy will fight, and pfizer will win. to the deepest pockets to the spoils.

Cytotec (http://www.drugdelivery.ca/s3182-s-CYTOTEC.aspx)