FDA approves Aptar's needle-free rescue treatment for severe hypoglycemia25 Jul 2019
Aptar’s nasal Unidose device - the result of a 10-year customer collaboration - marks the first FDA approval of a prescription drug using the company’s patented Unidose Powder System.
AptarGroup's Unidose Powder System has been approved by the FDA for an intranasal, needle-free rescue treatment drug intended to treat severe hypoglycemia in people with diabetes.
This marks the first FDA approval of a prescription drug using Aptar’s patented Unidose Powder System and is Aptar’s first combination of a drug delivery device with a protective active packaging container.
Solution for nasally administered powder treatments
Aptar’s Unidose Powder System is a single-use, ready-to-use one-step nasal delivery device which can deliver a powder formulation in an emergency situation quickly and easily. During such an event, the patient or caregiver presses a small plunger on the bottom of the device to release the drug in a single powder puff into the nose, where the drug can be quickly absorbed via the nasal mucosa. Aptar’s Unidose Powder System is an alternative to injectable kits that may require assembly, including a multistep, time-consuming process of mixing powder and liquid.
Patented Unidose and Bidose technology platforms
Aptar’s Unidose and Bidose platforms are robust, primeless, and easy-to-use systems with 360° functionality and precise nasal drug delivery. They offer biotech and pharmaceutical companies effective and reliable single or two-shot intranasal delivery for a variety of medicines including potential life-saving drugs and treatments of severe conditions. The devices can also integrate wireless connectivity technologies.
Integrated active packaging containerThis is the first approval and customer launch combining the technologies of Aptar Pharma and Aptar CSP Technologies. The novel container, which protects and stores the Unidose Powder System, was developed by Aptar CSP Technologies, the global material science unit of Aptar, providing innovative, highly engineered advanced active packaging solutions that protect sensitive drug products. The container incorporates Aptar’s three-phase Activ-Polymer technology which ensures extended moisture protection for the shelf-life of the drug, mitigating the impact of changing environmental conditions associated with temperature and relative humidity.
Accelerated development support
This innovative therapy in the field of diabetes is an example of a Combination Product submission and benefited from Aptar Pharma’s Services offering a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to accelerate approval.
“We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the FDA for the first intranasally delivered, needle-free rescue treatment for severe hypoglycemia that provides a more patient-friendly delivery approach. Our active packaging container helps to protect the device and better ensure its quality until the moment of use,” commented Gael Touya, President, Aptar Pharma. “This project marks a nearly 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments with patient-friendly delivery systems worldwide.”
Stephan Tanda, Aptar’s President and CEO added: “This successful approval confirms the value that we are bringing to our customers in the highly competitive pharmaceutical and biotech industries. With decades of experience in the long-term testing and development phases that are required by regulatory agencies, we are building a stronger solutions platform for the future, and this launch is a glimpse of that future. Our lab and analytic service capabilities combined with our unique drug delivery devices and active packaging solutions create tremendous value for our customers and help them secure approval. The ultimate end result is that we help expand access to life-saving treatments with our patient-friendly systems.”
Pioneer in Phenylketonuria to begin clinical trial with gene therapy
15 Jan 2020
BMN 307 represents a potential third PKU treatment option from BioMarin and its second gene therapy clinical program.Read more
Catalent launches direct-to-patient clinical supply services
14 Jan 2020
Multiple options provide increased flexibility for sponsors.Read more
Biogen to acquire novel clinical-stage asset from Pfizer
14 Jan 2020
PF-05251749 complements the company’s pipeline of potential disease-modifying therapies for Alzheimer’s and Parkinson’s diseases.Read more
French regulator agrees to partial resumption of Tellomak trial patient recruitment
14 Jan 2020
The French National Agency for Medicines and Health Product Safety (ANSM) has agreed that Innate Pharma’s Tellomak (lacutamab) Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) in ...Read more
Lupin could face FDA regulatory action over Tarapur API facility
13 Jan 2020
India’s Lupin Pharmaceuticals warned Monday it could face regulatory sanctions from the US Food and Drug Administration over its Tarapur active pharmaceutical ingredient (API) manufacturing facility.Read more
Partnership formed to develop and commercialise ready-to-use medicine
13 Jan 2020
The product being developed will use proprietary drug formulation technology platform Arestat to deliver new reformulations of existing, complex products.Read more
ReadCoor to commercially launch spatial sequencing platform
10 Jan 2020
Platform gives researchers access to previously undiscovered data to guide evaluation and validation of new drug targets, pathogen identification, disease diagnosis, and the advancement of regenerative medicine.Read more
CPhI and AAPS partner to expand expert scientific content at CPhI North America
10 Jan 2020
CPhI and the American Association of Pharmaceutical Scientists (AAPS) today announced a partnership to expand the scientific content of activities sponsored by CPhI, including CPhI North America—the only event to bring the entire North American pharmac...Read more
Mylan recalls batches of Nizatidine capsules after nitrosamine detected in API
9 Jan 2020
The US arm of generic and specialty pharma company Mylan Pharmaceuticals has recalled three lots of its heartburn drug Nizatidine in capsule form amid fears of possible nitrosamine contamination.Read more
New HQ for developer of world's first fully automated drug discovery platform
8 Jan 2020
End-to-end robotic platform provides biotechnology companies, pharmaceutical corporations and academic centres with cost-effective and reproducible drug discovery data.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation