International Approvals: Oral-lyn, Abraxane, DepoDur

Yael Waknine

November 12, 2007

November 12, 2007 — India's Central Drugs Standard Control Organization has approved a regular insulin spray for use in patients with diabetes and prediabetes, as well as albumin-bound paclitaxel particles for injectable suspension for the treatment of breast cancer. Australia's Therapeutic Goods Administration has approved a sustained-release liposome formulation of morphine sulfate injection for the relief of postoperative pain following major orthopedic, abdominal, or pelvic surgery.

Regular Insulin Oral Spray ( Oral-lyn) for Diabetes in India

On November 1, India's Central Drugs Standard Control Organization approved a regular insulin oral spray ( Oral-lyn, Generex Biotechnology Corp, distributed by Shreya Life Sciences Pvt). The product can be used as a preventative pharmacologic agent by people with prediabetes to delay disease onset and by type 2 diabetics to delay the onset of insulin dependence. It also may be used in place of subcutaneous injections in diabetic patients who require insulin.

"The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity," the company says on its Web site, adding that the product represents an ideal prandial insulin because it can be conveniently administered immediately before meals with little prospect of hypoglycemia.

Other benefits expected to improve patient compliance and thereby reduce diabetic complications include needle-free (pain-free) technology and ease of self-administration via the precise RapidMist device.

Insulin oral spray previously was approved for use in Ecuador; long-term clinical trials are ongoing in Canada and Europe to support its safety and efficacy.

A similar product, human insulin inhalation powder ( Exubera, Pfizer, Inc), previously was approved by the US Food and Drug Administration in January 2006 for the control of hyperglycemia in adult diabetic patients.

Albumin-Bound Paclitaxel Injection ( Abraxane) for Breast Cancer in India

On October 18, India's Central Drugs Standard Control Organization approved albumin-bound paclitaxel particles for injectable suspension ( Abraxane, Abraxis Bioscience, Inc, marketed by Biocon Ltd) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

The suspension consists only of albumin-bound paclitaxel nanoparticles, eliminating the need for standard steroid or antihistamine premedication to prevent solvent-based hypersensitivity reactions. As a result of lowered toxicity, higher doses of paclitaxel may be administered over a decreased infusion time. The approval was based on data from a pivotal phase 3, multicenter clinical study of 460 women who were randomly assigned to receive either albumin-bound paclitaxel particles (260 mg/m2) infused over 30 minutes or 175 mg/m2 of paclitaxel ( Taxol, Bristol-Myers Squibb) plus standard steroid and antihistamine premedication infused over 3 hours. Of the patient population, 41% received the study drug as first-line therapy, and 59% received it as second-line or greater therapy; 77% had been previously exposed to anthracyclines. Results showed that treatment with the higher-dose albumin-bound paclitaxel yielded significantly higher reconciled target lesion response rates overall (21.5% vs 11.1%; P = .003), as well as specifically in patients who had failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy (15.5% vs 8.4%). No statistically significant difference in overall survival was observed between groups.

According to a news release, the company will be initiating a worldwide head-to-head phase 3 trial to compare weekly albumin-bound paclitaxel to docetaxel ( Taxotere, sanofi-aventis) given every 3 weeks in the treatment of first-line metastatic breast cancer.

Albumin-bound paclitaxel previously was approved for this indication by the US Food and Drug Administration in January 2005.

Sustained-Release Morphine Epidural ( DepoDur) for Postsurgical Pain in Australia

On October 22, Australia's Therapeutic Goods Administration approved a sustained-release liposome formulation of morphine sulfate injection ( DepoDur, Pacira Pharmaceutical, Inc, marketed by Orphan Australia Pty Ltd) for the relief of postoperative pain following major orthopedic, abdominal, or pelvic surgery.

The single-dose modified-release formulation uses proprietary technology to provide pain relief for up to 48 hours. It is administered via the lumbar epidural route at a maximum recommended dose of 10 mg; appropriate monitoring must be maintained for 48 hours.

According to a company news release, the product is expected to be available in Australia from February 2008.

Morphine sustained-release liposome formulation previously was approved by the US Food and Drug Administration in May 2004.

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