The champagne corks didn’t pop on Friday at BioDeliverySciences International, but BDSI could commemorate another milestone.
The drug development firm filed an investigational new drug application with the Food and Drug Administration for its Bema LA product, which is designed as a treatment for moderate to severe pain.
“Anytime a company files an IND, it’s a significant event,” Mark Sirgo, president and chief executive officer of BDSI, said. “Filing of the IND allows you to begin evaluating the product in humans.
It’s an important event with the caveat that you’ve got a number of trials to go through before you can file a new drug application.”
BDSI, which is publicly traded (Nasdaq: BDSI), has high hopes for its product. The company estimates that if approved it could generate between $250 million and $500 million in annual sales.
Bema LA refers to the means of delivering the drug (Bema) and the active ingredient (LA).
“We have not disclosed what the active ingredient is,” Sirgo said. “This is a very competitive space. We believe we have the most advanced product at this stage and therefore are choosing not to disclose the active ingredient for competitive reasons.”
The pain killer is a powerful drug, however.
“It is not as addictive as morphine,” Sirgo said. “It’s approved in an alternative dosage form.”
In a statement, the company said the “LA will be a formulation of an analgesic which is already FDA-approved, which is substantially more potent than morphine, but which BDSI believes has a lower risk of serious adverse reactions and abuse.”
The Bema portion of the title refers to how the drug is delivered. Bema refers to “bioerodable mucoadhesive disc”, a technology BDSI has licensed. The disc is inserted in the mouth, and the painkiller it absorbed through the oral cavity.
The combination of the drug and the method of delivery could mean a big hit for BDSI.
“It will be the only product that contains this active incredible that can be delivered through (the mouth), which give it a rapid onset of action,” Sirgo explained. “In addition, the active ingredient is not absorbed when taken via a swallowed tablet. The alternative is to take it as an injectable, and you can see the advantages of doing it orally.”
The company met with the FDA in November before filing the IND application.
BDSI has two other drugs undergoing review. Emezine is for the treatment of nausea and vomiting, and its new drug application is under review. Fentanyl is undergoing Phase III clinical trial. It is for treatment of pain in cancer victims. BDSI has other drugs under development, Sirgo added.
The company targets what it calls “acute” treatment opportunities, including pain, anxiety, nausea and vomiting and infections.
BDSI went public in June of 2002 and raised $8.8 million in a secondary stock offering last October. The company employs some 20 people.