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Aviptadil

Pharmacologic Category

  • Synthetic Vasoactive Intestinal Peptide

Pharmacology

Aviptadil is a synthetic vasoactive intestinal peptide (VIP) that binds uniquely to receptors on alveolar type II cells in the lung, the same cells that bind the severe acute respiratory syndrome coronavirus (SARS-CoV-2) via their angiotensin-converting enzyme 2 receptors. VIP protects those cells and the surrounding pulmonary epithelium by blocking cytokines, preventing apoptosis, and upregulating the production of surfactant (Javitt 2020).

Distribution

Vd: 14 mL/kg.

Excretion

Renal (35% within 4 hours, 90% within 24 hours).

Half-Life Elimination

Plasma: ~1 to 2 minutes.

Use: Labeled Indications

See Off-label uses.

Off Label Uses

Coronavirus disease 2019 (COVID-19)

In vitro and animal studies demonstrate the activity of aviptadil against coronaviruses (eg, severe acute respiratory syndrome coronavirus [SARS-CoV], SARS-CoV-2, and potential decrease in pulmonary inflammation [Javitt 2020], [Temerozo 2020]. A case series describes clinical improvement after receiving intravenous aviptadil in patients with acute respiratory failure due to coronavirus disease 2019 (COVID-19); however, no conclusions about the safety and efficacy of aviptadil can be made until randomized, controlled clinical trials are performed [Youssef 2020]. Aviptadil is currently in phase II/III clinical trials to include patients with acute respiratory failure due to COVID-19 [NIH 2020a], [NIH 2020b].

Dosing: Adult

Note: The FDA issued an emergency use investigational new drug (IND) authorization and expanded access protocol for aviptadil for the treatment of coronavirus disease 2019 (COVID-19) patients with acute respiratory failure. The expanded access protocol allows for aviptadil to be distributed in the US and administered intravenously by health care providers, as appropriate, to treat COVID-19 patients with acute respiratory failure (https://www.neurorxpharma.com/our-services/usa-licensed-physicians). In addition, other phase II/II multicenter clinical trials are currently ongoing and enrolling in medical centers across the US (see ClinicalTrials.gov). Dosing will be provided after clinical trials have demonstrated efficacy.

Dosing: Pediatric

Note: The FDA issued an emergency use investigational new drug (IND) authorization and approved an expanded access protocol for aviptadil for the treatment of coronavirus disease 2019 (COVID-19) patients with acute respiratory failure. The expanded access protocol allows for aviptadil to be distributed in the United States and administered intravenously by health care providers, as appropriate, to treat COVID-19 patients ≥12 years of age with acute respiratory failure (see ClinicalTrials.gov) (NeuroRx 2020; NIH 2020b). Current manufacturer protocol should be used for specific dosing information.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Aviptadil is currently under investigation for use in the treatment of coronavirus disease 2019 (COVID-19) (see ClinicalTrials.gov). At this time, safety data are limited.

Frequency not defined:

Cardiovascular: Bigeminy (Javitt 2020), flushing (Javitt 2020), hypotension (Javitt 2020; Youssef 2020), tachycardia (Javitt 2020)

Gastrointestinal: Diarrhea (Javitt 2020; Youssef 2020)

Pregnancy Considerations

Aviptadil is under evaluation for the treatment of acute respiratory failure due to coronavirus disease 2019 (COVID-19). Pregnant patients are currently excluded from clinical trials but may be eligible for open label treatment under compassionate use (NIH 2020a).

Data collection to monitor maternal and infant outcomes following exposure to COVID-19 during pregnancy is ongoing. Health care providers are encouraged to enroll females exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/) or the PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) (415-754-3729; https://priority.ucsf.edu/).

The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have developed an algorithm to aid practitioners in assessing and managing pregnant women with suspected or confirmed COVID-19 (ACOG 2020; SMFM 2020). Interim guidance is also available from the Centers for Disease Control and Prevention for pregnant women who are diagnosed with COVID-19 (CDC 2020).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.