• The Food and Drug Administration (FDA) has approved generic formulations of
divalproex sodium extended-release tablets (Depakote),
according to a report by Reuters on July 30. The drug is approved to treat
epilepsy, bipolar disorder, and migraine headache. Various generic
manufacturers have received the agency's green light to produce the
• The FDA has approved valproic acid delayed-release capsules
(Stavzor) for marketing, according to an announcement by Noven Pharmaceuticals
Inc. on July 30. Although the active ingredient is not a new molecular entity,
the manufacturer's proprietary enteric soft-gel capsule formulation makes
it a brand-name product and purports to protect against gastric reflux and
irritability, the company's announcement asserted. The prescribing
information is posted at<www.fda.gov/cder/foi/label/2008/022152lbl.pdf>.
• The FDA has issued a not-approvable letter for the new drug application of
iloperidone, an antipsychotic developed by Vanda
Pharmaceuticals. According to a Reuter's report on July 28, the company
told analysts that the FDA had required additional data on the long-term
effects of the drug and its efficacy in comparison with placebo and currently
available antipsychotics such as olanzapine and risperidone. The future
development of iloperidone remains unclear.
• The package insert of methylphenidate extended-release
tablets (Concerta) was revised in June to incorporate changes to the
sections on contraindictions, warnings and precautions, adverse reactions, and
patient counseling information.
Hypersensitivity to methylphenidate is noted as a contraindication for
prescribing the drug. The risk of serious cardiovascular events, including
sudden death and other serious events in adults taking usual doses of
stimulants for ADHD, are described. Postmarketing reports of adverse reactions
have been added to the package insert as well as to the medication guide for
The FDA announcement on the labeling revisions is posted at<www.fda.gov/medwatch/SAFETY/2008/jun08.htm#Concerta>.
• The FDA issued a safety warning for health care professionals and the
public about the risk of serious injection-site reactions associated with
naltrexone extended-release injectable suspension (Vivitrol)
on August 12. Patients are advised to contact their physicians if they
experience pain, swelling, tenderness, bruising, pruritus, or redness at the
injection site that does not improve or worsens within two weeks. Physicians
are advised to refer promptly patients with serious reactions to a surgeon.
This warning was based on 196 reports of injection-site reactions so far,
including cellulitus, induration, hematoma, abscess, and necrosis from
patients who received this intramuscular injection.
• A bill for a federal "academic detailing" program intended to
provide nonindustry medical information to physicians was introduced in the
Senate on July 31 (S 3396), according to a press release by the Senate Special
Committee on Aging.
If passed, the legislation will set up a system to provide physicians and
other health care professionals with information on prescription drugs to
counter the promotional efforts of pharmaceutical sales representatives. One
of the sponsors of the bill, Sen. Herb Kohl (D-Wis.), called it "an
important alternative to the way doctors currently get their information about
drugs" in the press release.
Proposed actions including issuing grants to develop independent
educational materials for physicians and other prescribers and sending trained
health care professionals, such as pharmaceutical representatives, to
doctors' offices to promote these independent materials. Reps. Henry
Waxman (D-Calif.) and Frank Pallone (D-N.J.) introduced the same bill in the
House of Representatives (HR 6752).
The Senate Special Committee on Aging announcement is posted at<aging.senate.gov/hearing_detail.cfm?id=301620&>.
• Massachusetts Gov. Deval Patrick (D) has signed into law a regulation that
restricts pharmaceutical companies' gifts to health care professionals,
according to a report in the August 11 Boston Globe. The state
legislature had passed the bill, which requires pharmaceutical and medical
device companies to publicly disclose gifts to health care professionals that
are worth more than $50. Also, certain types of gifts, such as sports tickets
and free travel, are banned. An earlier effort in the state legislature to ban
all industry gifts to physicians had failed to gain full support. This
legislation was proposed in an attempt to control the state's escalating
health care costs since it began mandating health insurance for all residents
two years ago, the report noted.
• Forest Laboratories presented favorable results from a phase 3 clinical
trial of once-daily memantine extended-release in treating
patients with moderate to severe Alzheimer's disease at the 2008
Alzheimer's Association International Conference on Alzheimer's
Disease (ICAD) in Chicago in July.
In the randomized, double-blind, placebo-controlled trial sponsored by the
company, 677 patients who were taking a cholinesterase inhibitor (for example,
donepezil, galantamine, or rivastigmine) were given either placebo or 28
mg/day of memantine for 24 weeks. The symptom severity, measured by change
from baseline on the Severe Impairment Battery and the Clinician's
Interview-Based Impression of Change Plus Caregiver Input scales, was
statistically significantly better in patients taking memantine than in those
taking placebo. The adverse events associated with memantine were infrequent
and included dizziness, diarrhea, and headache.
• TauRx Therapeutics, a Singapore-based pharmaceutical company, presented
results from a phase 2 clinical trial showing efficacy of a proprietary oral
formulation of methylthionium chloride (Rember) on the cognition of patients
with Alzheimer's disease at the ICAD. The active ingredient is a chemical
and biological dye often used as a staining agent. The company is studying its
effects as an inhibitor of the tau protein aggregation, which has been linked
to Alzheimer's disease.
In the double-blind, multidose, clinical trial conducted in the United
Kingdom and Singapore, 321 patients were randomized to receive either the
active drug or placebo. After six months of treatment, patients taking the
active drug at 60 mg three times daily had statistically significantly better
cognitive scores on the subscale of the Alzheimer's Disease Assessment
Scale (ADAS) than those who took placebo, according to a press release from
• Disappointing results from a phase 3 clinical trial of
tarenflurbil (Flurizan) were presented at the ICAD. The
investigational drug targets the beta-amyloid protein build-up, but the
18-month, randomized, double-blind, placebo-controlled trial in 1,649 patients
with mild Alzheimer's disease failed to meet its primary efficacy
endpoints as measured by the cognition and activities of daily living
subscales of the ADAS. Myriad Genetics announced that it would abandon the
development of this molecule.
• GlaxoSmithKline said in July that it entered into a collaborative deal with
Actelion, a Swiss biopharmaceutical company, to develop and market an
investigational drug, almorexant, for treatment of insomnia.
Almorexant, known as an orexin receptor antagonist, is being studied in phase
3 clinical trials evaluating its safety and efficacy in adults and elderly
patients with primary insomnia.
• The Pharmaceutical Research and Manufacturers of America (PhRMA) released a
report on July 24 listing more than 300 new drugs under investigation by
pharmaceutical companies to treat various mental illnesses. Dementia
treatments lead the research categories, with 89 products being developed,
followed by products for depression and anxiety disorders.