Cephalon Inc.'s (CEPH) pain management franchise will be facing new competition in the form of Onsolis, which received FDA approval on Jul 16.

BioDelivery Sciences International's (BDSI) Onsolis is a rapid-acting buccal fentanyl product indicated for the treatment of breakthrough cancer pain (BTP) in opioid tolerant patients.

Onsolis is the first branded product that will be competing directly with Actiq and Fentora for a share in the highly-competitive BTP market. We believe that Onsolis could offer certain advantages over both Actiq and Fentora.

The Onsolis patch, which is designed to adhere quickly and begin dissolving without patient effort, could be easier to use than Actiq. Actiq is available in a lollypop form and patients are required to actively manipulate the lollypop around the mouth until the entire lozenge has dissolved. This can take up to 30 minutes.

Therefore, Onsolis could find takers in patients who are in severe pain and are

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Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

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