The US Food and Drug Administration (FDA) has approved rabeprazole for the short-term (up to 8 weeks) treatment of gastro-oesophageal reflux disease (GERD) in adolescents aged 12 years and older.

The approval was based on a 12-week, multicentre, open-label, randomised, parallel-group study with enrolled 111 adolescents patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD. Patients were randomized to receive rabeprazole 10 mg or 20 mg once daily for 8 weeks.

Efficacy results demonstrated that once-daily treatment with rabeprazole 20 mg for 8 weeks reduced the severity and frequency of GERD symptoms compared with symptoms prior to treatment.

The adverse events reported without regard to relationship to rabeprazole that occurred in >2% of 111 patients included headache (9.9%), diarrhoea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%).

Source: www.fda.gov and www.docguide.com as accessed on July 2008

Advanced Medical Optics has received U.S. Food and Drug Administration clearance for its fifth-generation IntraLase femtosecond laser.

The fifth-generation model — called the iFS advanced femtosecond laser — is capable of creating a corneal flap in less than 10 seconds and features an inverted bevel-in side cut angle designed to enhance flap lift, increase postoperative flap adhesion and improve the biomechanical stability of the cornea. The laser is also capable of performing fully customized IntraLase-enabled keratoplasty, the release said.

Compared with prior models, the fifth-generation platform features a faster repetition rate, tighter spot separation, lower energy, a high-resolution digital video microscope and a newly designed user interface.

The model is also ergonomically designed to improve surgeon comfort.

The United States Food and Drug Administration (FDA) has approved quetiapine fumarate (Seroquel) for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or divalproex. Quetiapine is also approved for the treatment of schizophrenia, and is the only single agent approved by the FDA for the treatment of both depressive and acute manic episodes associated with bipolar disorder.

The FDA approval was based on 2 multicentre, randomised, double-blind, placebo-controlled clinical trials which are part of the clinical trial program known as BOLDER (Bipolar Depression). These 2 studies evaluated quetiapine when used as an adjunct therapy to lithium or divalproex in the maintenance treatment of adults with bipolar I disorder. Pooled study results indicated that patients treated with quetiapine plus lithium or divalproex had a risk reduction of 70% relative to those in the placebo arm for time to recurrence of a mood event. This reduction in risk was significant for both recurrence of manic episodes and recurrence of depressive episodes. The proportion of patients who relapsed when treated with quetiapine was 19.3% versus 50.4% of patients on placebo.

The US Food and Drug Administration (FDA) has approved atomoxetine for maintenance treatment of ADHD in children and adolescents. Atomoxetine is the first FDA-approved nonstimulant to treat ADHD in children, adolescents, and adults.

The long-term, international, multicentre study, which was reviewed by the FDA as part of its decision to grant this approval, employed a treatment discontinuation design. In the study, 604 patients initially received acute open-label treatment with atomoxetine. After 10 weeks, 69% of patients qualified as responders were re-randomised to double-blind treatment with either atomoxetine or placebo for 9 months. A second 6-month randomisation occurred after approximately 1 year of treatment, with 81 patients taking atomoxetine and 82 patients in the placebo group.

Results of both randomisation phases showed that patients treated with atomoxetine had significantly greater continuous response rates versus patients taking placebo. Additionally, relapse rates for those discontinuing treatment after 1 year were lower than the relapse rates for patients who discontinued treatment during the 6 months following the open-label treatment phase.

Atomoxetine was generally well tolerated. The most common side effects reported in the study were headache and nasopharyngitis.

The US Food and Drug Administration (FDA) has approved aripiprazole as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar 1 disorder with or without psychotic features in adults.

This approval of aripiprazole is based on results from a 6-week, randomised, double-blind, placebo-controlled study in adults with manic or mixed episodes of bipolar 1 disorder who had an inadequate response to a 2-week, lead-in phase of mood stabiliser monotherapy (lithium or valproate). At study endpoint, add-on aripiprazole was superior to lithium or valproate with adjunctive placebo in the reduction of the Young-Mania Rating Scale (Y-MRS) Total Score and the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score for Mania.

The most commonly observed adverse reactions with adjunctive aripiprazole akathisia, insomnia and extrapyramidal disorder. The most common adverse reactions associated with discontinuation in adjunctive aripiprazole-treated patients were akathisia and tremor. Mean weight gain was low (0.6 kg for adjunctive aripiprazole vs. 0.2 kg for adjunctive placebo)

The US Food and Drug Administration (FDA) has approved approved a new recommended starting and target dose of 15 mg daily for aripiprazole monotherapy in the treatment of bipolar 1 disorder in adults.

The approval of the starting dose of 15 mg daily for aripiprazole is based on results from two 3-week, randomised, double-blind, placebo-controlled studies in adults with manic or mixed episodes of bipolar 1 disorder. At the 3-week study endpoint, aripiprazole was superior to placebo in the reduction of the Y-MRS Total Score and CGI-BP Severity of Illness Score for Mania.

The US Food and Drug Administration (FDA) has approved lisdexamfetamine dimesylate for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults. Lisdexamfetamine is the first and only once-daily prodrug stimulant approved to treat adults with ADHD.

The trial that led to the FDA approval was a double-blind, placebo-controlled, 4-week study with dose escalations in 414 adults aged 18 to 55 years. In this study, adults with ADHD experienced significant improvements in ADHD symptom control within 1 week of treatment with once-daily lisdexamfetamine. Treatment with lisdexamfetamine at all doses studied (30, 50, and 70 mg) was significantly more effective than placebo, providing a reduction in ADHD Rating Scale (ADHD-RS-IV) scores ranging from 16.2 to 18.6 points. Investigators also measured the efficacy of lisdexamfetamine with the Clinical Global Impressions-Improvement (CGI-I) scale and found that the percentage of subjects taking lisdexamfetamine who rated "improved" ranged from 57% to 61% across all doses and was significantly greater than placebo.The most commonly reported adverse events in this study were decreased appetite, difficulty falling asleep, and dry mouth.

The U.S. FDA has approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.

Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin. Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots.

The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites giving them additional choice for treatment.

The fibrinogen and thrombin proteins in Artiss are derived from human plasma, collected from FDA-licensed plasma centers. Both proteins undergo purification and virus inactivation treatments to reduce the risk of blood-transmissible infections. 

Source: http://www.fda.gov/ accessed on 19th march 2008

The Food and Drug Administration (FDA), on January 18, 2007, granted accelerated approval for etravirine 100 mg tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI), an antiviral drug that helps to block reverse transcriptase, an enzyme necessary for HIV virus replication. It is the first NNRTI to demonstrate antiviral activity in patients with NNRTI-resistant virus.

Etravirine is indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV -1) infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.

On October 30, the FDA approved brimonidine tartrate/timolol maleate 0.2%/0.5% topical ophthalmic solution to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy because of inadequately controlled IOP.

The recommended dosing for the alpha-adrenergic–receptor agonist plus beta-adrenergic–receptor inhibitor topical solution is 1 drop in the affected eye approximately every 12 hours; at least 5 minutes should elapse before and after administration of another topical product.

Use in children aged younger than 2 years is not recommended.

Approval of the combination product was based on data from 12-month pivotal trials, showing its use provided an additional decrease of 1 to 3 mm Hg in IOP vs brimonidine alone and an additional decrease of 1 to 2 mm Hg vs timolol alone during the first 7 hours after dosing.

Although the IOP-lowering effect of the combination product was slightly less than that of combination therapy with twice-daily timolol 0.5% solution and 3 times daily brimonidine 0.2% solution, it was associated with a decreased level of self-reported sleepiness in patients aged older than 40 years.

Adverse events reported in approximately 5% to 15% of patients using brimonidine/timolol solution included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritis, ocular burning, and stinging.

The US Food and Drug Administration (FDA) has approved a rivastigmine transdermal system for the treatment of mild to moderate Alzheimer's dementia and mild to moderate dementia associated with Parkinson's disease.

The approval in Alzheimer's dementia was based on data from the Investigation of transDermal Exelon in ALzheimer's disease (IDEAL) study, which showed that use of the rivastigmine 9.5-mg/day once-daily patch and twice-daily oral administration of a 6-mg capsule both yielded similarly significant mean improvements vs. placebo in cognitive function. Approval in Parkinson's disease was based on the EXelon in PaRkinson's disEaSe dementia Study ( EXPRESS ), which showed that rivastigmine oral therapy yielded significant improvements compared with placebo in terms of cognitive function and overall functioning. These data were judged to be applicable to the patch formulation as well.

The most commonly reported adverse events in patients receiving the 9.5-mg/24-hour rivastigmine patch that occurred at a frequency of at least 5% and incidence greater than placebo were nausea, vomiting and diarrhea.

Rivastigmine patches are available in 2 sizes: 5 cm 2 (4.6-mg/24-hour dosage) and 10 cm 2 (9.5-mg/24-hour dosage). Treatment should be initiated with a 4.6-mg/day patch applied once daily to the back, chest, or upper arm. Uptitration to the dosage of 9.5-mg/day may be considered after 4 weeks of treatment and good tolerability. Higher doses of the rivastigmine patch are not recommended because they did not confer appreciable benefit in clinical trials and were linked to a significant increase in the risk for adverse events.

When switching patients from capsules to oral solution formulations, those receiving a total daily dose of less than 6 mg of the oral formulation should initially use the 4.6-mg/24-hour patch. Initial use of the 9.5-mg/24-hour patch is advised for patients taking a total daily oral dose ranging from 6 to 12 mg. The first patch should be applied on the day following the last oral dose. In addition, patches should be replaced every 24 hours, and the time of day used should be kept consistent. Exposure of the patch to external heat sources (e.g., excess sunlight, saunas, and solarium) for long periods should be avoided.