This is a disposable nasal spray device made by Aptar that is pre-filled with two doses of a medicine for sequential administration in each nostril by a caregiver or patient. This device is appropriate for the delivery of a larger volume dose or when a medical episode is not adequately controlled after the administration of the first dose. No products have been approved yet by the FDA using this device.

There are approximately 40 prescription medicines approved by the FDA in a nasal spray formulation. Many include antihistamines and steroids to treat seasonal allergies (e.g., Flonase) and are available as generic (and OTC) medicines. Others include medicines such as Imitrex (sumatriptan) to treat migraines that are also available in injectable and oral forms. Nasal spray drugs can be locally or centrally-acting and are easily and quickly absorbed through the nasal mucosa for rapid relief. For patients fearful of needles, a nasal spray is a less threatening, convenient alternative when available.

There are three common types of nasal spray devices: unit-dose, bi-dose, and multi-dose. A unit-dose device is for single-use, pre-filled, already-assembled, disposable products such as NARCAN (naloxone nasal spray) and IMITREX (sumatriptan nasal spray). It is ideal for urgent use treatments. A bi-dose device is described above. A multi-dose device is ideal for chronic-use medicines such as FLONASE. Each device is already-assembled and pre-filled with many doses for an extended period of use (e.g., a month, season). It should be discarded after it is empty.

CMO is the acronym for contract manufacturing organization. A CMO can provide some or all of the following services to its clients in the pharmaceutical industry: mixing, compounding, filling, assembling, labeling, packaging, testing and serialization. Summit is the only CMO in the country that is solely focused on the production of nasal spray products. Summit is one of two CMOs in the USA that can produce unit-dose and bi-dose nasal sprays at commercial scale under cGMP conditions and is approved by the FDA and the EMA to produce nasal spray medicines in the USA and Europe, respectively.

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