The research was undertaken as a result of concerns raised by the FDA that the nasal spray could cause allergic reactions. The review by the FDA said allergic reactions might be induced by the combination of the nasals spray’s active ingredient and a preservative called chlorobutanol.
Nastech’s response consisted of an extensive comparison of Nastech’s product with the innovator drug Miacalcin manufactured by Novartis AG. Both products are used in the tretament of osteoporosis. Results showed that there were no clinical safety concerns raised during the development of Nastech’s generic product. In particular, there were no cases of immediate hypersensitivity.
Nastech also said that chlorobutanol was used in other nasal sprays currently on the market.
Nastech’s formulation of the nasal spray does not utilize the company’s advanced tight junction drug delivery technology, which is currently being used in development of its proprietary pipeline of peptide and protein therapeutics.