BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced that the U.S. Food and Drug Administration (FDA) have permitted all for file BDSI's fresh remedy submission (NDA) for BEMA™ Fentanyl that be submit by October 31, 2007, for the parliament of breakthrough cancer shooting pain encircled by opioid patient patients. The approval of the filing bearing the FDA has made an pilot trade name that the NDA be roundly terminated to warrant a substantive examination. A crucial decree by means of FDA is planned in August 2008.
If BEMA™ Fentanyl is qualified by the FDA, BDSI is expected to receive milestone payments from its commercial partner, Meda AB, totaling $30 million and could inaugurate reception imperial ancestral revenues from the goods in fix of precipitate as fourth quarter of 2008. BDSI believe that BEMA™ Fentanyl would be the subsequent product to enter the U.S. unstop market for approved psychotherapy for breakthrough cancer pain, a market which is expected to outdistance $1.5 billion complete the next several years.
In September 2007, BDSI announced a license agreement by Meda AB for the conveyance rights in the U.S., Canada, and Mexico for BEMA™ Fentanyl. In August 2006, Meda AB secured from BDSI the rights to publicize BEMA™ Fentanyl in Europe. Plans for submit a regulatory application in Europe be on the budge.
BEMA™ Fentanyl consists of a trifling, dissolvable, polymer lp, formulate with the opioid narcotic fentanyl for application to the buccal (inner bin liner of cheek) membranes. As once announced, the efficacy grades from the pivotal Phase III efficacy try-out in patients with breakthrough pain associated with cancer demonstrated that patients treat with BEMA™ Fentanyl have a vitally greater moderation anguished as early as 15 accounts (study former endpoint) relate to patients treated with placebo. A subsequent safe place gain comprehension of demonstrated a great tolerability profile, plus a requirement of oral exasperation or ulceration associated to product rule and employment.
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Bio Delivery Sciences International is looking for better ways to administer the drugs. The development-stage firm takes already approved drugs that are normally delivered intravenously and reformulates them into oral treatments. Drugs delivered through its BEMA and Bioral systems are being studied to treat acute pain and fungal infections, respectively.
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