In February the U.S. Food and Drug Administration (FDA) approved the selective alpha-2A agonist Intuniv (guanfacine) extended-release tablets for use as adjunctive therapy to stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children
and adolescents aged 6 to 17. Intuniv is the first once-daily nonstimulant to be approved for use alone or in combination
with stimulants for treatment of ADHD. The approval is based on results from a nine-week, placebo-controlled study of Intuniv
when given in combination with a stimulant to children and adolescents with ADHD.
The prescribing information is posted at <www.accessdata.fda.gov/drugsatfda_docs/label/2009/022037lbl.pdf>.
In March the FDA announced that new data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use
the medication during pregnancy. Topiramate is approved to treat certain types of seizures in people who have epilepsy and
to prevent (but not relieve) the pain of migraine headaches. Cleft lip and cleft palate, collectively called oral clefts,
are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester
of pregnancy, a time when many women do not know they are pregnant. The announcement was prompted by data collected from the
North American Antiepileptic Drug Pregnancy Registry, which indicated the increased risk. Based on the data, topiramate will
have a stronger warning in its prescribing information. The pregnancy category will be changed to Pregnancy Category D, meaning
that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant
women may outweigh the risk in certain situations. The FDA previously designated the drug as Pregnancy Category C because
of the lack of human data.
Details about the labeling change are posted at <www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245777.htm>.
In March the FDA convened a two-day meeting to seek the Molecular and Clinical Genetics Panel's expert opinion and input on
scientific issues concerning genetic tests that make medical claims and are marketed directly to consumers. In particular
the panel focused on test results that consumers can obtain without clinician involvement. Numerous molecular diagnostic tests
have been developed based on genetic variations that are known or believed to contribute to a disease or that can help select
appropriate treatment. The FDA's regulatory challenge is to assure that benefits of this work may be appropriately delivered
to patients and consumers, while ensuring that risks are appropriately managed, said the agency in its executive summary of
The executive summary is posted at <www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM245660.pdf>.
In February Forest Laboratories Inc. and Gedeon Richter Plc. announced preliminary top-line results from an eight-week, phase
2 clinical trial of the novel investigational antipsychotic agent cariprazine as an adjunctive therapy in treatment of major depressive disorder. Cariprazine is currently undergoing phase 3 trials for
the separate and additional indications of schizophrenia and bipolar mania. The companies are considering conducting an additional
phase 2 dose-response trial examining a wider range of doses.
The announcement is posted at <www.frx.com/news/PressRelease.aspx?ID=1347817>.
Researchers evaluating the efficacy and tolerability of escitalopram , a selective serotonin reuptake inhibitor, in alleviating the frequency and severity of menopausal hot flashes reported their
results in the January 19 JAMA . The multicenter, eight-week, randomized, double-blind, placebo-controlled, parallel-group trial enrolled 205 women (95 African
American, 102 white, and 8 other) from July 2009 to June 2010. Among healthy women, use of escitalopram (10-20 mg/d) compared
with placebo resulted in fewer and less-severe menopausal hot flashes at the eight-week follow-up.
An abstract of the article is posted at <http://jama.ama-assn.org/content/305/3/267.abstract>.
Transcept Pharmaceuticals Inc. announced in March that the first patient has been enrolled in a phase 2 clinical study to
evaluate TO-2061, a low-dose form of ondansetron, as an adjunctive treatment for obsessive-compulsive disorder (OCD) in patients who have responded
inadequately to currently approved treatments.
Approximately 50 percent of patients do not respond adequately to standard first-line treatment with currently approved OCD
medications, including the selective serotonin reuptake inhibitors and the tricyclic agent clomipramine. There is no FDA-approved
augmentation therapy for these treatment-resistant patients.
More about the study is posted at <www.transcept.com/content/view/103/99/>.
In March Euthymics Bioscience Inc. announced the initiation of an advanced clinical study of its lead product candidate EB-1010 for the treatment of major depressive disorder. The TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects) trial is a
phase 2b/3a clinical trial to assess the safety and efficacy of EB-1010, a novel serotonin-preferring triple reuptake inhibitor.
The trial will be conducted at 25 centers throughout the United States, and the company plans to enroll about 300 subjects.
Patient recruitment is under way, and top-line results are expected in mid-2012.
More information is posted at <www.euthymics.com/press-releases/euthymics-bioscience-initiates-triade-trial-for-major-depression/>.
A report in the March 9 JAMA by Michelle Roseman, B.A., of the Department of Psychiatry at McGill University in Montreal, and her colleagues stated that
disclosure of conflicts of interest related to the funding of biomedical research disappear when study results are included
in meta-analyses of trials of pharmacological treatments. Among a group of meta-analyses of pharmacological treatments published
in high-impact biomedical journals, information concerning primary study funding and author conflicts of interest for the
included randomized, controlled trials were only rarely reported, said the study's authors, who warned, "Without acknowledgement
of conflicts of interest due to industry funding or author-industry financial ties from randomized, controlled trials included
in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised."
An abstract of the report is posted at <http://jama.ama-assn.org/content/305/10/1008.short>.
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