16:58 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Tonix stops Phase III of PTSD candidate on lack of separation from placebo

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) said it will stop the Phase III HONOR trial of Tonmya (Sublingual TNX-102) to treat military-related post-traumatic stress disorder (PTSD) after the candidate showed "inadequate separation" from placebo at an...
23:42 , Nov 30, 2017 |  BC Week In Review  |  Company News

Omeros, Par settle Omidria patent infringement lawsuit

In October, Omeros Corp. (NASDAQ:OMER) said it and Par Pharmaceuticals Inc. settled a patent infringement lawsuit concerning Par's proposed generic version of Omeros' Omidria ketorolac/phenylephrine. Par, which Endo International plc (NASDAQ:ENDP) acquired in 2015, had...
23:02 , Nov 10, 2017 |  BC Extra  |  Company News

Omeros soars on single Phase III plan for OMS721

Omeros Corp. (NASDAQ:OMER) soared $4.08 (29%) to $18.17 Friday after announcing late Thursday that FDA will accept a single Phase III trial with a primary endpoint of proteinuria reduction to support approval of OMS721 to...
21:48 , Apr 20, 2017 |  BC Week In Review  |  Clinical News

TNX-102 SL: Ph III HONOR started

Tonix began the double-blind, placebo-controlled, U.S. Phase III HONOR trial to evaluate 5.6 mg sublingual TNX-102 daily at bedtime for 12 weeks in about 550 patients. An IDMC will perform an interim analysis when efficacy...
21:37 , Jan 27, 2017 |  BC Week In Review  |  Clinical News

TNX-102 SL: Ph II AtEase data

The double-blind, U.S Phase II AtEase trial in 231 patients with military-related PTSD showed that once-daily 2.8 mg sublingual TNX-102 SL given at bedtime missed the primary endpoint of improving CAPS-5 total symptom severity score...
22:21 , Dec 21, 2016 |  BC Week In Review  |  Clinical News

TNX-102 SL regulatory update

FDA granted breakthrough therapy designation to TNX-102 SL from Tonix to treat post-traumatic stress disorder (PTSD). In 1Q17, the company plans to start the Phase III HONOR trial of the sublingual formulation of cyclobenzaprine, a...
07:00 , Mar 17, 2016 |  BC Innovations  |  Distillery Therapeutics

Therapeutics: Adrenergic receptor a1 (ADRA1)

Genitourinary INDICATION: Incontinence In vitro and rat studies identified an iminopyridine-based ADRA1 antagonist that could help treat overactive bladder (OAB). Chemical synthesis and in vitro testing of iminopyridine analogs yielded a compound that bound ADRA1...
08:00 , Dec 11, 2014 |  BC Innovations  |  Targets & Mechanisms

Terazosin reborn

In searching for compounds to treat stroke or sepsis, a Chinese team has found a new activity-and possibly a new indication-for an old drug. Terazosin, a generic a-blocker used in hypertension, inhibited apoptosis and extended...
07:00 , Jul 28, 2014 |  BC Week In Review  |  Clinical News

Vazculep phenylephrine regulatory update

FDA approved an NDA from Flamel for Vazculep phenylephrine to treat clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Flamel plans to launch the adrenergic receptor alpha 1 ( ADRA1 )...
08:00 , Jan 9, 2014 |  BC Innovations  |  Distillery Therapeutics

Indication: Ophthalmic disease

Indication Target/marker/pathway Summary Licensing status Publication and contact information Ophthalmic disease Ophthalmic disease Adrenergic receptor a1 (ADRA1); ADRA2; adenylate cyclase 1 (ADCY1; AC1) Mouse studies suggest antagonizing ADRA1 or stimulating ADRA2 could help treat Stargardt...