BOTHELL – Nastech Pharmaceutical’s vitamin B-12 nasal spray is closer to regulatory approval, as the U.S. Food and Drug Administration indicated Monday the Bothell firm doesn’t need to conduct further studies.
An inspection of the vitamin B-12 manufacturing facility is needed before the FDA can bestow its final approval, according to the agency’s “approvable letter” to Nastech. The final label information for Nascobal spray needs to be reviewed as well.
“The couple of things we need to do are really minor,” said Gordon Brandt, Nastech’s executive vice president of clinical research and medical affairs. “It will be a sort path to approval, we believe.”
He added it’s possible the FDA will approve the nasal spray by the year’s end. The application for approval was submitted at the end of last December.
Nascobal already is available in a nasal gel form developed by Nastech. It’s designed for patients with conditions that make them vulnerable to vitamin B-12 deficiency, including multiple sclerosis, Crohn’s disease and AIDS.
The deficiency can cause anemia, intestinal problems and nerve damage.
Because people with certain diseases can’t absorb the vitamin well in pill form, approximately 116,000 patients get B-12 injections monthly, despite the availability of the Nascobal gel since 1997.
Last year, sales of the gel approached $5 million. Bringing the spray form to market should help spur more patients to try Nascobal, according to Nastech.
“It’s a more convenient, patient-friendly product,” Brandt said.
While Nastech developed Nascobal, the company isn’t in charge of marketing and selling the product. That task falls to Questcor Pharmaceuticals Inc. of Union City, Calif., which paid Nastech $18 million in 2003 for the rights to Nascobal. The deal came after Nastech ended a previous partnership on the drug.
But Nastech continues to make Nascobal gel for Questcor and will do the same with the spray. Brandt said the spray initially will be made as Nastech’s manufacturing plant in New York, though production could eventually shift to the company’s new manufacturing facility in Bothell.
Reporter Eric Fetters: 425-339-3453 or etters@heraldnet.com.
Talk to us
> Give us your news tips.
> Send us a letter to the editor.
> More Herald contact information.
