LAVAL, Quebec–(BUSINESS WIRE)– De farmaceutische contract productielocatie van Altasciences in Philadelphia, PA, is door Respira Technologies, Inc. gekozen om gepatenteerde geneesmiddelen te vervaardigen voor ‘s werelds eerste therapie voor het stoppen met roken door inhalatie. Deze behandeling maakt gebruik van RespiRx™, een vibrating mesh nebulizer (VMN) met een onderhoudsvrije wegwerpcartridge die het risico van misbruik en niet-naleving door de patiënt vermindert en mogelijk elimineert.
Na een succesvolle Pre-Investigational New Drug (IND)-bijeenkomst met de Food en Drug Administration (FDA) op 18 november, is Respira van plan om hun IND-aanvraag in 2022 in te dienen onder de 505(b)(2)-regelgevingsroute.
Altasciences Chosen by Respira Technologies, Inc. as Drug Product Manufacturing Partner for the World’s First Inhaled Nicotine Replacement Therapy (NRT)
LAVAL, Quebec–(BUSINESS WIRE)– Altasciences’ pharmaceutical contract manufacturing site in Philadelphia, PA, has been chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the world’s first inhaled smoking cessation therapy. This treatment uses RespiRx™, a vibrating mesh nebulizer (VMN) with a maintenance-free disposable cartridge that reduces and potentially eliminates the risk of patient misuse and non-compliance.
Following a successful Pre-Investigational New Drug (IND) meeting with the Food and Drug Administration (FDA) on November 18, Respira is intending to submit their IND application in 2022 under the 505(b)(2) regulatory pathway.
Respira also plans to create a larger platform approach for active pharmaceutical ingredient (API) delivery, taking advantage of the multi-drug capabilities of their proprietary platform drug delivery system. To date, 91 potential APIs have been identified.
“Our team chooses best-in-class partners, and working with Altasciences has been a great experience overall. Altasciences is playing a big role in advancing Respira’s ambition to secure the FDA’s authorization on a potential breakthrough drug product, and through this collaborative environment, we can change the world of drug development. Altasciences is agile, flexible, and quick, while providing the proven expertise and capability required for cGMP pharma drug product manufacturing. We are thankful for their fast response rate, creativity, and ability to take on the needs of nimble start-ups like Respira,” said Mario Danek, Founder and CEO at Respira Technologies, Inc.
Altasciences leverages deep expertise in formulation, development, and manufacturing, as well as flexible processes and significant investments in state-of-the-art technologies, to support clients in their research and commercial manufacturing requirements.
“We are delighted to be partnering with Respira Technologies, Inc. on this new and exciting technology. Our team has truly enjoyed having the opportunity to work with a world-class organization that quickly makes key decisions to ensure we meet accelerated timelines,” stated Ben Reed, Executive Vice President of Operations at Altasciences.
More information on Respira Technologies, Inc.’s program can be found here.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
+1 514 601-9763