Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares in BioDelivery Sciences International (NASDAQ:BDSI) are collapsing by more than 25% today following news that its promising topical gel for diabetic neuropathy failed in an important phase 3 trial.
So What: BioDelivery Sciences focuses on developing medications for pain, and the failure of its Clonidine topical gel is a blow given that diabetic neuropathy is a major market indication.
The drug, which did perform well in mid stage trials, failed to deliver a statistically better improvement in treating pain associated with diabetic neuropathy versus placebo.
The news was surprising given that an interim look at data from the phase 3 trial suggested that it was effective. That interim trial data prompted the company to expand the trial to include an additional 80 patients, but those patients responded differently to the drug, causing the trial to fail to meet its primary endpoint, according to the company.
Now What: The drug's failure is a setback, but the company doesn't appear ready to toss the drug into the dust bin -- at least not yet. BioDelivery Sciences plans to crunch the data from the trial in hopes of designing additional trials that could eventually succeed. Since that could or could not happen, investors are right to be cautious.
However, investors should also know that this isn't the company's only iron in the fire. BioDelivery Sciences already markets the opioid dependence drug Bunavail, which won FDA approval last summer, and it, along with its collaboration partner Endo Pharmaceuticals, filed for FDA approval of its opioid pain medicine Belbuca in December. A decision on Belbuca is expected on October 23rd. Since there's no guarantee that Bunavail will be a commercial success, or that Belbuca will win a FDA go ahead, this company is too risky for me, but these other programs could suggest that this one is worth keeping an eye on.