Triptans

BioDelivery Sciences Announces Agreement to Acquire U.S. and Canadian Rights to FDA-approved ELYXYB™ for the Acute Treatment of Migraine

Retrieved on: 
Wednesday, August 4, 2021

RALEIGH, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, announced today that it entered into an agreement on August 3, 2021 with Dr. Reddy’s Laboratories Limited to acquire the U.S. and Canadian rights to ELYXYB (celecoxib oral solution), the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.

Key Points: 
  • In pivotal studies, ELYXYB demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks.
  • The results from pivotal studies established the efficacy of ELYXYB in the treatment of acute migraine.
  • ELYXYBs unit-dose oral solution makes it convenient for patients to take it immediately upon emergence of acute migraine attacks.
  • We believe that this profile, coupled with the ready-to-use oral solution, make ELYXYB an attractive option for the acute treatment of migraine in adults.

Zosano Pharma Announces Issuance of U.S. Patent for Method of Rapidly Achieving Therapeutic Levels with M207 for the Acute Treatment of Migraine

Retrieved on: 
Tuesday, July 20, 2021

11,058,630 titled Method of Rapidly Achieving Therapeutic Concentrations of Triptans for the Treatment of Migraines.

Key Points: 
  • 11,058,630 titled Method of Rapidly Achieving Therapeutic Concentrations of Triptans for the Treatment of Migraines.
  • This latest patent adds to Zosanos M207 patent portfolio, which now includes two U.S. patents with claims covering composition of matter and method of use for M207 with expirations in 2037.
  • Zosano believes there is a significant need for new acute treatment options since 74% of migraine patients experience inadequate treatment response.
  • All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

Antares Pharma to Present at the Raymond James Human Health Innovations Conference

Retrieved on: 
Tuesday, June 15, 2021

EWING, N.J., June 15, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Raymond James Human Health Innovations Conference.

Key Points: 
  • EWING, N.J., June 15, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that Robert F. Apple, President and Chief Executive Officer, is scheduled to present at the Raymond James Human Health Innovations Conference.
  • Antares Pharmas FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.
  • This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
  • Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.

Antares Pharma Reports First Quarter 2021 Financial and Operating Results

Retrieved on: 
Thursday, May 6, 2021

Furthermore, our commercial organization implemented an enhanced targeting strategy that reinforces the expansion opportunities for XYOSTED and the relaunch of NOCDURNA.

Key Points: 
  • Furthermore, our commercial organization implemented an enhanced targeting strategy that reinforces the expansion opportunities for XYOSTED and the relaunch of NOCDURNA.
  • Antares Pharma\xe2\x80\x99s FDA-approved products include XYOSTED\xc2\xae (testosterone enanthate) injection, OTREXUP\xc2\xae (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.
  • Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.
  • The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release.

Antares Pharma Announces Poster Presentation at the Pediatric Endocrine Society 2021 Virtual Annual Meeting

Retrieved on: 
Monday, May 3, 2021

Vogiatzi commented, \xe2\x80\x9cWe were pleased to be able to share this novel data extrapolation with our colleagues and peers.

Key Points: 
  • Vogiatzi commented, \xe2\x80\x9cWe were pleased to be able to share this novel data extrapolation with our colleagues and peers.
  • There are currently no approved autoinjectors to deliver subcutaneous testosterone in this medically underserved population.
  • Antares Pharma\xe2\x80\x99s FDA-approved products include XYOSTED\xc2\xae (testosterone enanthate) injection, OTREXUP\xc2\xae (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.
  • Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.

Pulmatrix Hosting Key Opinion Webinar on PUR3100 (Orally Inhaled DHE) Therapy for the Treatment of Acute Migraine

Retrieved on: 
Thursday, April 15, 2021

Dr. Tepper will discuss the current treatment landscape and unmet medical need in treating patients with acute migraine.

Key Points: 
  • Dr. Tepper will discuss the current treatment landscape and unmet medical need in treating patients with acute migraine.
  • Russell Clayton, Pulmatrix\'s Strategic Advisor and Medical Director, will then discuss the PUR3100 development plan and pre-clinical data.
  • Ted Raad, Pulmatrix\'s CEO, will also provide a brief corporate overview, including the business strategy behind PUR3100, a dry powder iSPERSE formulation of DHE for pulmonary delivery to treat acute migraine.
  • PUR3100 is currently in pre-clinical investigation as an orally inhaled migraine therapy with Phase 1 and Phase 2 data anticipated in 2022.\nA live Q&A session will follow the formal presentations.

Cipla receives final approval for generic version of GlaxoSmithKline's IMITREX® (Sumatriptan Nasal Spray, 20 mg)

Retrieved on: 
Tuesday, March 2, 2021

MUMBAI, India, March 2, 2021 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereinafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mgfrom the United States Food and Drug Administration (U.S. FDA).

Key Points: 
  • MUMBAI, India, March 2, 2021 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereinafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mgfrom the United States Food and Drug Administration (U.S. FDA).
  • Cipla's Sumatriptan Nasal Spray USP, 20 mg is an AB-rated generic therapeutic equivalent version ofGlaxoSmithKline's Imitrex Nasal Spray.
  • Imitrex Nasal Spray is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
  • According to IQVIA (IMS Health), Imitrex Nasal Spray 20mg and its generic equivalents had US sales of approximately $53.3M for the 12-month period ending December 2020.

Cipla receives final approval for generic version of GlaxoSmithKline's IMITREX® (Sumatriptan Nasal Spray, 20 mg)

Retrieved on: 
Tuesday, March 2, 2021

MUMBAI, India, March 2, 2021 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereinafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mgfrom the United States Food and Drug Administration (U.S. FDA).

Key Points: 
  • MUMBAI, India, March 2, 2021 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereinafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mgfrom the United States Food and Drug Administration (U.S. FDA).
  • Cipla's Sumatriptan Nasal Spray USP, 20 mg is an AB-rated generic therapeutic equivalent version ofGlaxoSmithKline's Imitrex Nasal Spray.
  • Imitrex Nasal Spray is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
  • According to IQVIA (IMS Health), Imitrex Nasal Spray 20mg and its generic equivalents had US sales of approximately $53.3M for the 12-month period ending December 2020.

Zosano Pharma Requests Type A Meeting with the FDA to Review Resubmission Plans for Qtrypta™ New Drug Application

Retrieved on: 
Monday, January 4, 2021

The purpose of the Type A meeting is to receive FDA input on the requirements for the resubmission of the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA) following the Complete Response Letter (CRL) received on October 20, 2020.

Key Points: 
  • The purpose of the Type A meeting is to receive FDA input on the requirements for the resubmission of the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA) following the Complete Response Letter (CRL) received on October 20, 2020.
  • Qtrypta is Zosanos proprietary investigational formulation of zolmitriptan delivered utilizing its proprietary transdermal microneedle system developed for the acute treatment of migraine.
  • The NDA included data on a total of 774 subjects across 5 trials who were administered or dosed with Qtrypta.
  • We have been working diligently to prepare the meeting package required at the time a Type A meeting request is submitted to FDA.

Deadline Reminder: Law Offices of Howard G. Smith Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Zosano Pharma Corporation (ZSAN)

Retrieved on: 
Tuesday, November 10, 2020

Investors suffering losses on their Zosano investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected] .

Key Points: 
  • Investors suffering losses on their Zosano investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected] .
  • The FDA also "raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company's clinical trials."
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • Law Offices of Howard G. Smith