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Posts Tagged ‘initiates’

Spinal Restoration Initiates Patient Enrollment For Phase III Study Of Company’s Biostat(R) System

Spinal Restoration, Inc. announced that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S…

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Zogenix Initiates Pivotal Phase 3 Clinical Trial For Novel Formulation Of Oral Controlled-Release Hydrocodone

Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain…

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QRxPharma Initiates Second Pivotal Phase 3 Study Of MoxDuo(TM)IR Dual-Opioid(TM) For NDA Submission

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo?IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone…

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QRxPharma Initiates Pivotal Phase 3 Study Of MoxDuo(TM)IR For Moderate To Severe Acute Pain

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced, as part of its Phase 3 program, the initiation of a registration (also called pivotal) trial (Study 008) comparing efficacy and safety profiles of MoxDuo(TM)IR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery…

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Adolor Corporation Initiates Clinical Testing In Opioid Bowel Dysfunction Program

Adolor Corporation (NasdaqGM:ADLR) announced the initiation of clinical testing of ADL7445, its proprietary, oral mu opioid receptor antagonist for the treatment of Opioid Bowel Dysfunction (OBD). The Phase 1, single ascending dose trial in healthy volunteers will assess safety and tolerability of the compound and will be followed by a multiple ascending dose study in early 2010…

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QRxPharma Initiates Comparative Phase 2 Proof-of-Concept Study For MoxDuo(TM) IV Pain Therapy

QRxPharma Limited (Pink Sheets: QRXPY; ASX: QRX) announced the initiation of a Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of MoxDuo(TM) IV (intravenous morphine and oxycodone) versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery.

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PAION Initiates Phase Ib Study Of The Anesthetic/Sedative CNS 7056 In Volunteers Undergoing Colonoscopy

The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) announces the start of a Phase Ib multiple dose study with the new short-acting intravenous anesthetic/sedative CNS 7056 in volunteers undergoing colonoscopy. The randomized, open, dose-escalation multiple dose Phase Ib study will evaluate the sedation and recovery profile of CNS 7056 in volunteers undergoing colonoscopy.

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NanoBio Initiates FDA Approved Clinical Trial For Adjuvanted Intranasal Influenza Vaccine

NanoBio Corp. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for the Phase 1 clinical study of NB-1008, a seasonal influenza vaccine administered via a nasal dropper. NB-1008 uses a novel nanoemulsion-based adjuvant to achieve a robust immune response using only a small fraction of the antigen required by currently available injectable vaccines.

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PAION Initiates Phase II Trial With Its Anesthetic/Sedative CNS 7056

The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) announces the commencement of the initial Phase II study with CNS 7056, a new short-acting intravenous anesthetic/sedative. The study will enroll 100 patients undergoing diagnostic endoscopy of the upper gastrointestinal tract.

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KAI Pharmaceuticals Initiates Third Phase 2a Study In Program To Develop KAI-1678 For The Treatment Of Neuropathic Pain

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced the Company has initiated a third Phase 2a study of KAI-1678, a first-in-class, isozyme-selective, small peptide inhibitor of the epsilon protein kinase C pathway (epsilon PKC). The study has begun enrollment of patients for the treatment of chronic neuropathic pain associated with spinal cord injury (SCI).

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