FDA Approvals: Charité Artificial Disc, Concerta, Verisyse, Duet System, Spectrum Glide

Yael Waknine

October 28, 2004

Oct. 28, 2004 — The U.S. Food and Drug Administration (FDA) has approved an implantable spinal disc to replace damaged or worn out discs, a 72-mg daily methylphenidate HCl extended-release dose for adolescents with attention deficit hyperactivity disorder who are inadequately controlled at lower dosage strengths, a phakic intraocular lens for the reduction/elimination of myopia in adults, an automated system for FISH scanning of amniotic cells, and a hydrophilic antimicrobial catheter that combines ease of use with decreased risk of infection.

Charité Artificial Disc Replaces Damaged/Worn Out Spinal Discs

On Oct. 26, the FDA approved an implantable device (Charité Artificial Disc, made by DePuy Spine, Inc., a Johnson & Johnson Company) for the replacement of damaged or worn out spinal discs in the treatment of severe low back pain.

The disc is made of two metallic endplates and a movable high-density plastic center that is designed to help align the spine and preserve its ability to move. The implantation procedure is performed in one to two hours.

The approval was based on the results of clinical trials showing that patients receiving disc implants maintained spinal flexibility, showed improvements in pain and function, recuperated more quickly, required a shorter hospital stay, evinced higher satisfaction with the procedure, and were able to return to work more quickly (in 12 weeks vs six months) compared with patients undergoing spinal fusion surgery.

New Daily Dose of Methylphenidate (Concerta) for Adolescent ADHD

On Oct. 26, the FDA approved a new 72-mg daily dose for methylphenidate HCl extended-release tablets (Concerta, made by McNeil Consumer & Specialty Pharmaceuticals) for use in the treatment of adolescents with attention deficit hyperactivity disorder (ADHD). The tablets are also available in 18-, 27-, 36-, and 54-mg strengths.

The 72-mg dose can be administered as a single morning dose of two 36-mg tablets and is intended for use in patients not adequately controlled at lower doses of medication. According to a company news release, 80% of patients require dose escalation a few weeks after therapy initiation to effectively manage symptoms.

The approval was based on the results of a clinical study showing that the 72-mg methylphenidate dose significantly reduced symptoms of ADHD in adolescents aged 13 to 18 years.

Artisan Intraocular Lens Marketed as Verisyse in U.S. and Japan

On Sept. 13, the FDA approved the Artisan phakic intraocular lens (made by Ophtec B.V.), as reported in the Sept. 16 edition of this column. This lens will be marketed in the U.S. and Japan as Verisyse (made by Advanced Medical Optics).

The lens is intended for use as an alternative to laser surgery in the reduction or elimination of myopia ranging from –5.0 to –20.0 diopters in adults aged 21 years and older.

The lens is implanted behind the cornea and on top of the iris to allow the natural eye extra focusing power for higher-definition vision. A 15- to 30-minute procedure to implant the lens is performed on an outpatient basis and may be reversed if needed.

Expedited review status was previously granted by the FDA in August 2003.

System Indicated for Automated FISH Scanning of Amniotic Cells

On Sept. 20, the FDA approved an additional indication for an automated scanning microscope and image analysis system (Duet System, made by BioView, Ltd.), allowing its use in the diagnosis and monitoring of patients with genetic abnormalities in chromosomes X, Y, 13, 18, and 21.

The system allows dual methods of examining a single cell: morphologic analysis and analysis based on fluorescent in-situ hybridization (FISH) staining using direct labeled DNA probes for chromosomes X, Y, 13, 18, and 21. According to a company news release, the system generates increased amounts of information not provided by other technology to provide fast, accurate, and highly sensitive results.

The system was previously approved by the FDA for use as an in-vitro diagnostic tool and monitoring device for hematological pathologies by immunohistochemistry analysis of Giemsa-stained hematopoietic cells.

Hydrophilic Version of Antimicrobial Catheter (Spectrum Glide)

On Aug. 31, the FDA approved a hydrophilic-coated antimicrobial central venous catheter (Spectrum Glide minocycline/rifampin impregnated catheter, made by Cook Critical Care) for the prevention of catheter-related bloodstream infections in patients posing the greatest catheter placement challenges.

According to a company news release, the catheter's highly lubricious hydrophilic surface with impregnated antibiotics combines ease of use with protection against catheter-related infection.

Reviewed by Gary D. Vogin, MD

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