Analysis of Review Times for Recent 505(b)(2) Applications

Introduction The outbreak of the disease caused by the new coronavirus (COVID-19) has been affecting society’s routine and its patterns of interaction worldwide, in addition to the impact on the global economy. To date, there is still no clinically effective treatment for this comorbidity, and drug repositioning might be a good strategy considering the established clinical safety profile. In this context, since COVID-19 affects the respiratory tract, a promising approach would be the pulmonary drug delivery. Objective Identify repurposing drug candidates for the treatment of COVID-19 based on the data of ongoing clinical trials and in silico studies and also assess their potential to be applied in formulations for pulmonary administration. Method A narrative literature review was conducted between June and July 2020, by extracting the results from Clinical Trials, PubMed, Web of Science and Science Direct databases. Results By crossing the results obtained from diverse sources, 21 common drugs were found, from which only 4 drugs presented studies of pulmonary release formulations, demonstrating the need for greater investment and incentive in this field. Conclusion Even though the lung is a target that facilitates viral infection and replication, formulations for pulmonary delivery of suitable drugs are still lacking for COVID-19 treatment. However, it is indisputable that the pandemic constitutes a concrete demand, with a profound impact on public health, and that, with the appropriate investments, it will give the pharmaceutical industry an opportunity to reinforce the pulmonary delivery field.

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Analysis of Review Times for Recent 505(b)(2) Applications

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Recycled Translation: Repurposing Drugs for Stroke

Recycled Translation: Repurposing Drugs for Stroke

The pulmonary route as a way to drug repositioning in COVID-19 therapy

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