Nasal administration

Oragenics, Inc. Prepares Drug for Phase II Clinical Trials to Treat Concussion

Retrieved on: 
Tuesday, March 5, 2024

The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.

Key Points: 
  • The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.
  • A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated.
  • Phase II patients will be recruited between the ages of 18-55 in the acute phase following concussion.
  • “Preclinical intranasal targeting of the brain has been shown to improve outcomes in animals and safety margin following concussion.

Oragenics, Inc. Preparing for Phase II Clinical Trials to Treat Concussion

Retrieved on: 
Monday, February 5, 2024

Oragenics has begun the final process of synthesizing and formulating the drug needed for its Phase II clinical trial.

Key Points: 
  • Oragenics has begun the final process of synthesizing and formulating the drug needed for its Phase II clinical trial.
  • We are excited to get the Phase II clinical trials underway,” commented Dr. James “Jim” Kelly, Neurologist and Executive Director of the Marcus Institute of Brain Health and an advisor on the planned phase II trial.
  • The drug has a large safety margin between dosages used in the animal toxicology program and those used in the Phase I study and planned for the upcoming Phase II clinical trial.
  • Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients.

Tiziana Life Sciences Files New Patent Application for Combination Therapy of anti-CD3 (Foralumab) with GLP-1 Receptor Agonist for Additional Reduction of Obesity - Associated Inflammation

Retrieved on: 
Friday, January 5, 2024

Effectiveness of GLP-1ra non T2D obesity was recently shown in the >17,600 patient SELECT trial by Novo Nordisk (N Engl J Med 2023; 389:2221-2232(NCT03574597).

Key Points: 
  • Effectiveness of GLP-1ra non T2D obesity was recently shown in the >17,600 patient SELECT trial by Novo Nordisk (N Engl J Med 2023; 389:2221-2232(NCT03574597).
  • SELECT showed a 20% reduction of major adverse cardiovascular events (MACE) such as heart attack, stroke, and peripheral vascular disease, with semaglutide.
  • The risk of adverse cardiovascular events could be reduced further by the combination of intranasal foralumab and a GLP-1ra.
  • The patent application describes the potential for foralumab to provide additional risk reduction for heart attack, stroke, and peripheral vascular disease.

Chronic Rhinosinusitis with Nasal Polyps Market to Witness Upsurge in Growth at a CAGR of 10.03% During the Study Period (2019-2032), Examines DelveInsight

Retrieved on: 
Thursday, December 7, 2023

LAS VEGAS, Dec. 7, 2023 /PRNewswire/ -- DelveInsight's Chronic Rhinosinusitis with Nasal Polyps Market Insights report includes a comprehensive understanding of current treatment practices, chronic rhinosinusitis with nasal polyps emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • Leading chronic rhinosinusitis with nasal polyps companies such as AstraZeneca, Amgen, GlaxoSmithKline, Keymed Biosciences, Biohaven Pharmaceuticals, and others are developing novel chronic rhinosinusitis with nasal polyps drugs that can be available in the chronic rhinosinusitis with nasal polyps market in the coming years.
  • The promising chronic rhinosinusitis with nasal polyps therapies in the pipeline include FASENRA (benralizumab), TEZSPIRE (tezepelumab), Depemokimab/GSK3511294, CM310, NURTEC (rimegepant), and others.
  • Chronic rhinosinusitis is an inflammatory disease of the paranasal sinuses and nasal tube lining that lasts for more than 4 to 12 weeks.
  • To know more about chronic rhinosinusitis with nasal polyps treatment guidelines, visit @ Chronic Rhinosinusitis with Nasal Polyps Management

Chronic Rhinosinusitis with Nasal Polyps Market to Witness Upsurge in Growth at a CAGR of 10.03% During the Study Period (2019-2032), Examines DelveInsight

Retrieved on: 
Thursday, December 7, 2023

LAS VEGAS, Dec. 7, 2023 /PRNewswire/ -- DelveInsight's Chronic Rhinosinusitis with Nasal Polyps Market Insights report includes a comprehensive understanding of current treatment practices, chronic rhinosinusitis with nasal polyps emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • Leading chronic rhinosinusitis with nasal polyps companies such as AstraZeneca, Amgen, GlaxoSmithKline, Keymed Biosciences, Biohaven Pharmaceuticals, and others are developing novel chronic rhinosinusitis with nasal polyps drugs that can be available in the chronic rhinosinusitis with nasal polyps market in the coming years.
  • The promising chronic rhinosinusitis with nasal polyps therapies in the pipeline include FASENRA (benralizumab), TEZSPIRE (tezepelumab), Depemokimab/GSK3511294, CM310, NURTEC (rimegepant), and others.
  • Chronic rhinosinusitis is an inflammatory disease of the paranasal sinuses and nasal tube lining that lasts for more than 4 to 12 weeks.
  • To know more about chronic rhinosinusitis with nasal polyps treatment guidelines, visit @ Chronic Rhinosinusitis with Nasal Polyps Management

Nasus Pharma Announces Positive Clinical Results of Recent Phase 2 Study With FMXIN002 Intranasal Epinephrine

Retrieved on: 
Tuesday, December 5, 2023

TEL AVIV, Israel, Dec. 5, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a needle-free, powder-based Intranasal (PBI) product portfolio to address acute medical conditions announced positive results from its latest clinical study of intranasal powder-based Epinephrine.

Key Points: 
  • TEL AVIV, Israel, Dec. 5, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a needle-free, powder-based Intranasal (PBI) product portfolio to address acute medical conditions announced positive results from its latest clinical study of intranasal powder-based Epinephrine.
  • Nasus Pharma recently completed an additional phase 2 study (NP-006-Epinephrine) confirming the superiority and safety of its lead FMXIN002 Intranasal Epinephrine product.
  • The recent clinical study explored the safety and efficacy of FMXIN002 in its intended clinical dose and provided additional compelling evidence to the robustness of Nasus Pharma intranasal powder technology already tested in a  prior pilot study ( Tal, et al.
  • "This phase 2  study indicates that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration and other solution-based intranasal epinephrine programs in development.

US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal)

Retrieved on: 
Tuesday, October 24, 2023

AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal), a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA).

Key Points: 
  • AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal), a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA).
  • FLUMIST QUADRIVALENT, which is sprayed into the nose, has extensive data demonstrating comparable effectiveness and acceptable safety relative to other flu vaccines.
  • If approved at that time, FLUMIST QUADRIVALENT is anticipated to be available for self-administration in the US for the 2024/2025 flu season.
  • FLUMIST QUADRIVALENT now has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination.

ARS Reports Second Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, August 10, 2023

SAN DIEGO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the second quarter of 2023.

Key Points: 
  • Topline data from the company’s ongoing Phase 2 randomized, placebo-controlled study of neffy in urticaria patients are expected by the fourth quarter of 2023.
  • R&D Expenses: Research and development (R&D) expenses were $7.3 million for the quarter ended June 30, 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $13.3 million for the quarter ended June 30, 2023.
  • Net Loss: Net loss was $17.4 million for the quarter ended June 30, 2023.

Nasus Pharma Announces Publication Of Its Positive Clinical Results With FMXIN002 Intranasal Powder Epinephrine Spray In The Journal Of Allergy And Clinical Immunology In Practice

Retrieved on: 
Tuesday, August 8, 2023

TEL AVIV, Israel, Aug. 8, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the publication of positive results from a clinical study of intranasal powder-based Epinephrine.

Key Points: 
  • FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites.
  • The clinical study provides additional compelling evidence to the robustness of Nasus Pharma's intranasal powder technology already tested in other drugs.
  • "The publication of our results in a prominent scientific journal such as JACI: In Practice will ensure the dissemination of FMXIN002's promise within the relevant medical community."
  • Yet an additional advantage for powder-based formulation of epinephrine, a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms.

Nasus Pharma Announces Publication Of Its Positive Clinical Results With FMXIN002 Intranasal Powder Epinephrine Spray In The Journal Of Allergy And Clinical Immunology In Practice

Retrieved on: 
Tuesday, August 8, 2023

TEL AVIV, Israel, Aug. 8, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing needle-free, powder-based Intranasal (PBI) product portfolio, to address acute medical conditions announced the publication of positive results from a clinical study of intranasal powder-based Epinephrine.

Key Points: 
  • FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, user-friendly and reliable and could provide timely effective rescue for severe potentially life-threatening allergic reactions to food, medications and insect bites.
  • The clinical study provides additional compelling evidence to the robustness of Nasus Pharma's intranasal powder technology already tested in other drugs.
  • "The publication of our results in a prominent scientific journal such as JACI: In Practice will ensure the dissemination of FMXIN002's promise within the relevant medical community."
  • Yet an additional advantage for powder-based formulation of epinephrine, a drug that undergoes rapid degradation in the currently-available short shelf-life liquid dosage forms.