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Buccal in Medical Technology

Strativa Pharmaceuticals Announces Phase III Results for Loramyc(R) to Treat Oropharyngeal Candidiasis

... for a Phase III study of Loramyc(R) (miconazole Lauriad(R)) mucoadhesive buccal tablets, in the treatment of oropharyngeal candidiasis (OPC). Top line ... being marketed in France, is an antifungal delivered in a mucoadhesive buccal tablet designed to enable local once-daily dosing of the active ingredient ...

Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain

... results from a 12-week, Phase 3 clinical trial of FENTORA(R) (fentanyl buccal tablet) [C-II] in patients with breakthrough pain associated with a broad ... and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. Serious adverse events associated with all opioids are respiratory ...

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

... TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) ...

Cephalon Provides Clinical Update on Lestaurtinib in Relapsed Acute Myelogenous Leukemia

... include: NUVIGIL(R) (armodafinil) Tablets [C-IV], TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl ...

Strativa Pharmaceuticals Provides Product Pipeline Update

... FDA has informed BioAlliance Pharma, Strativa's development partner, that the agency did not accept its NDA for Loramyc(R) (miconazole) mucoadhesive buccal tablet (MBT) based on the lack of an imprint code on the tablet. Loramyc was approved in the European Union in 2007 and is currently marketed in ...

Cephalon Announces Positive Results from a Phase Three Study of NUVIGIL in Jet Lag Disorder

... AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), TREANDA(R) (bendamustine hydrochloride) for Injection, FENTORA(R) (fentanyl buccal tablet) [C-II], PROVIGIL(R) (modafinil) Tablets [C-IV], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), NUVIGIL and ...

Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression

... AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), TREANDA(R) (bendamustine hydrochloride) for Injection, FENTORA(R) (fentanyl buccal tablet) [C-II], PROVIGIL(R) (modafinil) Tablets [C-IV], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), NUVIGIL and ...

Cephalon Signs Option Agreement to Acquire Ception Therapeutics

... AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), TREANDA(R) (bendamustine hydrochloride) for Injection, FENTORA(R) (fentanyl buccal tablet) [C-II], PROVIGIL(R) (modafinil) Tablets [C-IV], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(R) ...

Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain

... of a complete response letter from the Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment for opioid-tolerant patients with non-cancer breakthrough pain. In its letter, the FDA requested that Cephalon ...

Journal of Clinical Oncology Publishes Study of Cephalon Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkin's Lymphoma

... France. The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), ...

TREANDA Demonstrates Substantial Efficacy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

... France. The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release ...

TREANDA Significantly Improves Clinical Outcomes in Patients with Chronic Lymphocytic Leukemia Compared to Chlorambucil

... France. The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release ...

Cephalon Announces Positive Results from Its Pivotal Study of TREANDA in Patients with Non-Hodgkin's Lymphoma

... France. The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release ...

Bema Fentanyl Demonstrates Substantial Transmucosal Delivery In Absolute Bioavailability Study

... was more than 70%, with 50% absorbed through the buccal mucosa (the inner lining of the cheek). The study ... opioid narcotic fentanyl, for application to the buccal membranes. Upon administration, BEMA(TM) Fentanyl ... amount of fentanyl absorbed directly through the buccal mucosa were substantial (70% and 50%, ...

BDSI Announces Positive Phase III Clinical Trial Results for BEMA Fentanyl

... disc, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. Upon administration, BEMA Fentanyl is ... control is attributable to the efficient, reliable absorption from the buccal mucosa, the ease of application of the BEMA Fentanyl product and the ...

Columbia Laboratories Reports Preliminary Findings from the Ongoing Data Analysis of the Phase III Clinical Study of PROCHIEVE 8% (progesterone gel) to Prevent Preterm Birth

... marketing of CRINONE(R) 8% (progesterone gel), PROCHIEVE(R) 8%(progesterone gel), PROCHIEVE 4% (progesterone gel), and STRIANT(R) (testosterone buccal tablet) in the U.S.; the timely and successful development of new products, including the clinical and regulatory path for possible development of ...

Cephalon Presents Positive Results for Fentora in Breakthrough Pain Associated with Neuropathic Conditions

... presented today at the 59th Annual Meeting of the American Academy of Neurology in Boston highlights data demonstrating that FENTORA(R) (fentanyl buccal tablet) [C-II] is beneficial for the treatment of breakthrough pain in patients with neuropathic pain who are already taking opioids ...

BDSI Announces Positive Key Secondary Efficacy Endpoint Results for Bema Fentanyl

... at 30 minutes). BEMA(TM) Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. Upon administration, BEMA(TM) Fentanyl is designed to deliver a rapid, reliable dose of drug across the mucous ...

Interim Analysis of Crinone Pregnancy Study to Be Published in American Society for Reproductive Medicine Journal

... deficiency and PROCHIEVE 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets STRIANT(R) (testosterone buccal system) for the treatment of hypogonadism in men. The Company's research and development programs include a vaginally-administered lidocaine product ...

Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine

... deficiency and PROCHIEVE 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets STRIANT(R) (testosterone buccal system) for the treatment of hypogonadism in men. For more information, please visit www.columbialabs.com. Safe Harbor Statement Under the Private ...

Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis

... immunotherapy by injection. About PreHistin PreHistin is a sublingual lozenge that delivers its active ingredient through the buccal membrane directly into the bloodstream. The active ingredient, cyanocobalamin, has a well-known safety profile and has been shown in studies to ...
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