By Don Long
The FDA this week said it will review two investigational drugs using the fast-track approval process, potentially speeding them to market clearance.
One of the products, Surfaxin, is used for treating acute respiratory distress syndrome (ARDS), and is being developed by Discovery Laboratories, of Doylestown, Pa. The other, brand-named Vitrase, is a drug for treating vitreous hemorrhage in the back portion of the eye, and is produced by Advanced Corneal Systems, of Irvine, Calif.
Surfaxin synthetically imitates the natural coating of the inside of the lungs, called surfactant. As a result of pneumonia, aspiration of gastric contents, contusion, inhalation of toxic gas or smoke, near drowning or a variety of other causes, the lungs can become inflamed. This condition can then lead to degrading of the natural coating and lung collapse.
An estimated 150,000 people suffer from ARDS each year in the U.S., about half of them dying.
Surfaxin is a synthetic replacement for the natural lung coating. It is used in solution to wash the interior of the lungs via an endotracheal tube, removing contaminants and helping the lungs to reopen and restore oxygenation. Since there is presently no FDA-approved treatment for the condition, Surfaxin has been designated an orphan drug, thus promoting its fast-track status.
Christopher Schaber, Discovery's vice president of regulatory affairs and quality assurance, told Bioworld Today that the company completed a Phase I trial of the product this past December. In giving the product fast-track designation, the FDA approved the launch of a 405-patient Phase II/III pivotal trial, but Schaber could not estimate when it will be completed.
Once the study is completed and the data analyzed, the FDA could consider approval in six months, cutting the usual timeline about in half, Schaber said. "Hopefully," he added, "approval could come in three to four months."
Besides its treatment for ARDS, Discovery is developing treatments for meconium aspiration syndrome, idiopathic respiratory distress syndrome and cystic fibrosis.
Similar to Surfaxin, Advanced Corneal's Vitrase was granted fast-track designation because it addresses a serious unmet medical need, in this case, bleeding in the back portion of the eye, which seriously compromises vision.
Diana Schmidt, vice president of development for Advanced Corneal, estimates approximately 450,000 cases of the condition annually in the U.S., and another 600,000 each year in Europe.
International Vitrase Phase III Trial On The Way
Vitrase (hyaluronidase) is an enzyme which serves to break up the hyaluronic acid in the vitreous jelly of the eye. This in turn allows the hemorrhaged blood to sink to the bottom of the eye where it dissipates through natural absorption, Schmidt told Bioworld Today.
The company has completed a Phase II clinical trial of Vitrase and, at the FDA's request, is doing a follow-up study of that trial which should be completed by year-end. Additionally, the company is launching an 800-patient Phase III international trial of the drug, with Schmidt predicting submission of results to the FDA "by the third or fourth quarter of the year 2000."
Founded in 1992, the company has not yet achieved commercialization of any products, but Vitrase is the more advanced of the two products the company is developing. Its other product, brand-named Corneaplasty, is a non-surgical system to correct refractive errors.