Anxiolytics

Bionomics BNC210 Expansion into Social Anxiety Disorder

Monday, May 10, 2021 - 11:00am

The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD.

Key Points: 
  • The slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption limited its use for the acute treatment of anxiety in patients with SAD.
  • A new solid dose tablet formulation of BNC210 has been successfully developed, showing much improved and rapid absorption over the previous liquid suspension formulation, and will be used for the Phase 2 efficacy clinical trials in SAD and PTSD.\n"Anxiety disorders are a significant burden for our communities and approximately 17 million American adults suffer from Social Anxiety Disorder.
  • Premier Research is recognised as a leading CRO supporting industry-sponsored PTSD studies and has conducted ~10 studies in this indication since 2014, including Bionomics\' RESTORE trial.
  • Collaborating again with Bionomics is the ideal way to leverage ourcollective experience in this space," said Krista Armstrong, PhD, Premier Research SVP, Clinical Development Services & Global Head of Neuroscience.

Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

Friday, April 30, 2021 - 5:00am

b'ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire) - Agilex Biolabs, Australia\'s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.\nLiz Doolin, Bionomics\' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning.

Key Points: 
  • b'ADELAIDE, AUS, Apr 30, 2021 - (ACN Newswire) - Agilex Biolabs, Australia\'s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.\nLiz Doolin, Bionomics\' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning.
  • "\nBionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical stage biopharmaceutical company.
  • Agilex Biolabs has been working closely with Bionomics for several years, supporting the PK regulated Bioanalysis of BNC210 and is privileged to be a part of this potential new treatment for anxiety and stressor-related disorders.
  • Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Game On! Nature's Bounty® Breaks into Gaming and Brain Health Supplement Categories with New Brain HP

Monday, April 26, 2021 - 2:08pm

Brain HP contains fast-acting L-theanine, an amino acid found in tea, to help improve reaction time and reduce errors while on task.

Key Points: 
  • Brain HP contains fast-acting L-theanine, an amino acid found in tea, to help improve reaction time and reduce errors while on task.
  • * Cognizn * is another key element as it provides citicoline, an important building block in the brain, at a dose clinically shown to support attention and focus.
  • "I hope this partnership with Nature\'s Bounty and Brain HP helps more gamers and streamers realize the importance of their health, and the impact it has on their career.
  • "\nThe new Nature\'s Bounty Brain products are currently available on Amazon.com and coming to a shelf near you at CVS and Meijer this spring.

Research Provides New Insight on Functional Changes That Regular Coffee Drinking has on The Brain

Tuesday, April 20, 2021 - 9:42am

These areas of the brain include the cerebellum, striatum, thalamus, parahipocampus, and the lingual and inferior occipital gyri1.\nInterestingly, the structural and connectivity differences observed among regular coffee drinkers in this research also occurred in non-coffee drinkers soon after they consumed a cup of coffee.

Key Points: 
  • These areas of the brain include the cerebellum, striatum, thalamus, parahipocampus, and the lingual and inferior occipital gyri1.\nInterestingly, the structural and connectivity differences observed among regular coffee drinkers in this research also occurred in non-coffee drinkers soon after they consumed a cup of coffee.
  • By using fMRI technology, we were able to observe the effect of coffee on the brain\xe2\x80\x99s functional connectivity and structure, and the differences between regular coffee drinkers and non-coffee drinkers, in real-time.
  • (2021) Habitual coffee drinkers display a distinct pattern of brain functional connectivity.
  • (2018) l - Theanine and caffeine improve target-specific attention to visual stimuli by decreasing mind wandering: a human functional magnetic resonance imaging study.

Novadoz Has a Fast Start to 2021 with Generic Launches of Albendazole, Droxidopa, Deferasirox Granules, and Pregabalin ER

Friday, April 23, 2021 - 3:28pm

Novadoz is the U.S sales and marketing affiliate for MSN\'s portfolio of finished dosage forms.

Key Points: 
  • Novadoz is the U.S sales and marketing affiliate for MSN\'s portfolio of finished dosage forms.
  • The company has commenced shipping of all the products which received approvals during Q1 2021.\nAlbendazole 200mg is marketed in bottles of 2 tablets.
  • Novadoz participated in a Day 1 launch of the product, coinciding with the expiration of the brand exclusivity.
  • The other niche offering includes Pregabalin ER 82.5mg, 165mg, and 330mg tablets available in bottles of 30.

Neurelis Announces Five Poster Presentations for the Annual Meeting of the American Academy Of Neurology

Monday, April 19, 2021 - 2:00pm

In addition, the data shows that patients reported feeling like their usual self within two hours after VALTOCO administration.

Key Points: 
  • In addition, the data shows that patients reported feeling like their usual self within two hours after VALTOCO administration.
  • To be able to continue on with your day is very meaningful for patients with seizure clusters.
  • In a long-term, open-label, repeat-dose clinical trial, the safety of VALTOCO was evaluated, and more than 4,000 seizures were treated.
  • Serious and fatal adverse reactions, including "gasping syndrome", can occur in neonates and low-birth-weight infants treated with benzyl alcohol-preserved drugs, including VALTOCO.

Multiple Former FDA Commissioners Voice Support for Reduced Nicotine Mandate; Proposed Legislation Would Be Game-Changing for 22nd Century

Thursday, April 1, 2021 - 3:06pm

By way of support, four former U.S. Food and Drug Administration (FDA) commissioners, Robert M. Califf, M.D.

Key Points: 
  • By way of support, four former U.S. Food and Drug Administration (FDA) commissioners, Robert M. Califf, M.D.
  • We believe that the Agency will advance their Comprehensive Plan and soon announce its simple, yet powerful reduced nicotine product standard.
  • Made from tobacco engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN is the only combustible product that complies with the FDAs proposed nicotine cap.
  • The designation will allow 22nd Century to communicate key features of VLN King and VLN Menthol King, including a headline claim of 95% less nicotine.

Next Generation Labs LLC has been granted a Notice of Allowance from China for its Process for The Preparation of (R-S) Synthetic Nicotine - Patent #201580069647.2

Monday, March 22, 2021 - 1:00pm

Since 2014, NGL has been the leading developer of tobacco-free synthetic nicotine for the vaping, oral nicotine and smoking markets.

Key Points: 
  • Since 2014, NGL has been the leading developer of tobacco-free synthetic nicotine for the vaping, oral nicotine and smoking markets.
  • In many instances, the nicotine contained in these products is not synthetic, tobacco-free or non-tobacco, but is in fact derived from tobacco sources.
  • About Next Generation Labs ('NGL'): Since 2014 NGL has been the world's largest manufacturer of S-isomer, R-S isomer and R-isomer synthetic nicotine under the federally-registered brand name TFN.
  • NGL's TFN products are manufactured under strict conditions to meet cGMP, USP and EU standards to achieve a level of 99.97% pure synthetic nicotine.

VistaGen’s Poster Presentation at the Anxiety and Depression Association of America’s 2021 Annual Conference Differentiates PH94B’s Mechanism of Action from Highly-Addictive Benzodiazepines

Monday, March 22, 2021 - 12:30pm

PH94Bs MOA is, therefore, fundamentally differentiated from the MOA of benzodiazepines such as alprazolam, diazepam and lorazepam, which are direct GABA-A receptor positive modulators.

Key Points: 
  • PH94Bs MOA is, therefore, fundamentally differentiated from the MOA of benzodiazepines such as alprazolam, diazepam and lorazepam, which are direct GABA-A receptor positive modulators.
  • Among VistaGens core goals is for PH94B to displace these and other widely-used but highly-addictive benzodiazepines in the acute treatment paradigm for SAD and other anxiety disorders and phobias.
  • PH94B also has therapeutic potential in a wide range of additional anxiety disorders and phobias.
  • To help differentiate PH94Bs mechanism of action from that of benzodiazepines, VistaGen studied whether PH94B had positive modulatory effects on GABA receptors.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Aquestive Therapeutics, Inc. (AQST)

Friday, March 12, 2021 - 5:30pm

Glancy Prongay & Murray LLP (GPM) reminds investors of the upcoming April 30, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Aquestive Therapeutics, Inc. (Aquestive or the Company) (NASDAQ: AQST ) securities between December 2, 2019 and September 25, 2020, inclusive (the Class Period).

Key Points: 
  • Glancy Prongay & Murray LLP (GPM) reminds investors of the upcoming April 30, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Aquestive Therapeutics, Inc. (Aquestive or the Company) (NASDAQ: AQST ) securities between December 2, 2019 and September 25, 2020, inclusive (the Class Period).
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at shareholders@glancylaw.com to learn more about your rights.
  • Its most advanced proprietary product candidate is Libervant, a buccal soluble film formulation of diazepam for the treatment of recurrent epileptic seizures.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.