FDA Approvals: ExAblate 2000, Luveris, OraDisc A, EpiLift, MammoSite

Yael Waknine

October 26, 2004

Oct. 26, 2004 -- The U.S. Food and Drug Administration (FDA) has approved a device that uses magnetic resonance imaging and ultrasound to target and destroy uterine fibroids, a recombinant human leuteinizing hormone (lutropin alfa) for use with follitropin alfa in the treatment of infertility, a new delivery system for amlexanox in the treatment of canker sores, an ophthalmic surgical device that eliminates the need for cutting of stromal flaps during keratomileusis surgery, and a less invasive version of a balloon catheter used in brachytherapy.

Device (ExAblate 2000) for Uterine Fibroid Ablation

On Oct. 22, the FDA approved a device (ExAblate 2000, made by InSightec, Ltd.) intended for use in uterine fibroid ablation in women who have completed child-bearing or do not intend to get pregnant. The FDA expedited review of the device due to its significant advantage over existing treatments, including hormone therapy, myomectomy, and hysterectomy.

The approval was based on the results of a study showing that the device reduced fibroid-related problems in 71% of 109 women with uterine fibroids. The study also found that 21% of patients required alternative surgical treatment for fibroids within a year. Labeling on the device indicates that no more than two treatments should be performed in a two-week period.

The device uses magnetic resonance imaging (MRI) to visualize the uterine anatomy, map the volume of fibroid tissue to be treated, and monitor uterine tissue temperature after heating with a focused, high-frequency, high-energy ultrasound beam that destroys the fibroid tissue.

Duration of the procedure is up to three hours and involves repeated targeting and heating of fibroid tissue while the patient lies in the MR machine. According to the FDA, this is the first application to combine the use of MRI with ultrasound and to use MR in monitoring tissue temperature.

The device may not be used for fibroids close to sensitive organs, such as the bladder or bowel, or for those outside the image area. The procedure is not intended for use in women desiring future pregnancy because its effects on conception, fetal development, and ability to carry a fetus to term have not been determined.

The FDA is requiring the company to conduct a three-year postmarketing study to assess the long-term safety and effectiveness of the device. The study will include a larger number of African-American women due to the increased incidence of uterine fibroids in this group and their underrepresentation in the original study.

Recombinant Human Luteinizing Hormone (Luveris) With Follitropin Alfa for Infertility

On Oct. 15, the FDA approved a recombinant human form of luteinizing hormone, lutropin alfa for injection (Luveris, made by Serono), for concomitant use with follitropin alfa for injection (Gonal-f, made by Serono), in the stimulation of follicular development in infertile hypogonadotropic hypogonadal (HH) women with profound luteinizing hormone (LH) deficiency (< 1.2 IU/L). The hormone has also been granted orphan drug status due to the low incidence of HH in the population.

Unlike urinary-derived human menopausal gonadotropins that provided LH-like activity in the past, the high purity and consistency of lutropin alfa allows clinicians the flexibility to precisely tailor doses to individual patient needs. In addition, lutropin alfa is administered subcutaneously rather than by intramuscular injection.

Adverse effects include headache, abdominal pain, nausea, ovarian hyperstimulation syndrome, breast pain, and ovarian cyst. Multiple births have been associated with gonadotropin treatments.

The drug is approved in more than 60 countries worldwide, including countries in the European Union, Asia, Latin America, and Australia.

Amlexanox MucoadhesivePatch (OraDisc A) for Canker Sores

On Sept. 29, the FDA approved a new transdermal delivery system for amlexanox (OraDisc A mucoadhesive patch, made by Access Pharmaceuticals, Inc.) for use in the treatment of aphthous ulcers in adults and adolescents aged 12 years and older with a normal immune system. The 2-mg amlexanox patch is applied to the inside of the mouth, where it gradually erodes while releasing an active ingredient.

The approval was based on the results of clinical trials that included pediatric patients aged 12 years and older, an important age group for this indication. One 700-patient, 28-day trial yielded positive survey results with respect to perceived effectiveness, ease of application, and ability of the device to remain in place.

Ophthalmic Surgical Device (EpiLift System) Eliminates Cutting of Stromal Flaps

On Sept. 20, the FDA approved an ophthalmic surgical device (EpiLift System, made by VisiJet, Inc.) for use in separating corneal tissue in a procedure similar to laser-assisted in situ keratomileusis (LASIK) surgery and known as laser epithelial keratomileusis (LASEK), or Epi-Lasik.

Epi-LASIK combines the instant results of LASIK with the stable long-term visual outcomes of photorefractive keratectomy. During the procedure, corneal epithelium is separated from Bowman's membrane in an intact sheet of viable tissue (Epi sheet) that is lifted away from the cornea to allow excimer laser reshaping of the corneal bed, then replaced. No microkeratome is needed, thus eliminating complications associated with traditional LASIK stromal flaps.

The device was approved for use in the European Union earlier this year.

Next Generation of MammoSite Device Has Thinner Shaft, Smaller Balloon Profile

On Sept. 22, the FDA approved a new version of a minimally invasive balloon catheter (MammoSite, made by Proxima Therapeutics, Inc.) for use in delivering partial breast irradiation after lumpectomy in women with early-stage breast cancer.

The new version of the device offers a thinner catheter shaft and a smaller balloon profile to further minimize intrusion into the lumpectomy cavity during brachytherapy.

The original version of the device was approved by the FDA in 2002.

Reviewed by Gary D. Vogin, MD


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