Tag: nasal spray

Categories : Cardiovascular DiseaseTags :

At-home Nasal Spray for Episodes of Arrhythmia

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Photo by CDC on Unsplash

A clinical trial led by Weill Cornell Medicine investigators showed that a nasal spray that patients administer at home, without a physician, successfully and safely treated recurrent episodes of a condition that causes arrythmia. The study, published in the Journal of the American College of Cardiology, provides real-world evidence that a wide range of patients can safely and effectively use the experimental drug etripamil to treat recurrent paroxysmal supraventricular tachycardia (PSVT) episodes at home. For many, this could spare the need for repeated hospital trips for more invasive treatments.

The study is the latest in a series of studies by lead author Dr James Ip, professor of clinical medicine at Weill Cornell Medicine and a cardiologist at New York-Presbyterian/Weill Cornell Medical Center, and colleagues to demonstrate the potential of nasal spray calcium-channel blocker etripamil as an at-home treatment for PSVT.

Patients with PSVT experience sudden and recurrent rapid heart rhythms triggered by abnormal electrical activity in the upper chambers of the heart.

Though the episodes are not commonly life-threatening, they can be frightening and cause shortness of breath, chest pain, dizziness or fainting and lead to frequent emergency department visits. Treatment for PSVT often requires hospitalisation to receive intravenous medication. Some patients undergo cardiac ablation.

Dr Ip and colleagues previously showed that almost two-thirds of patients with PSVT who took one or more doses of the calcium channel blocker etripamil without a physician present experienced symptom relief on average in 17 minutes.

The latest study builds on those findings, showing that etripamil is safe and effective under more real-world circumstances in a larger patient population, and could be safely used to treat multiple episodes of PSVT.

The new study enrolled 1116 patients at 148 sites in the United States, Canada and South America. It did not require a pretest dose supervised by a physician as the previous studies did. It also included patients with a history of atrial fibrillation or atrial flutter, who were excluded from the previous studies. Patients monitored their heart for one hour with a home electrocardiogram monitor after self-administering the first dose, took an additional dose if necessary, and were allowed to self-treat up to four PSVT episodes with etripamil. Two-thirds of the patients experienced relief within an hour, and the average time needed for symptom relief was 17 minutes. Mild, temporary nasal symptoms such as runny nose, nasal congestion or discomfort, and bloody nose were common after the first use of etripamil but became less common with subsequent use.

Source: Weill Cornell Medicine

Categories : Cardiovascular Disease New Compounds and TreatmentsTags :

Fast-acting Nasal Spray Could Treat Tachycardia Episodes

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Photo by Stephen Andrews

A fast-acting drug delivered as a nasal spray may someday allow patients with intermittent tachycardia to treat it themselves as soon as they develop symptoms, according to new research published in the Journal of the American Heart Association. The drug is still under development and awaiting approval in the US by the Food and Drug Administration.

“This is a potential new and exciting option for patients to safely self-treat their rapid heartbeat without direct medical supervision to avoid emergency room visits and medical interventions,” said lead author James E. Ip, MD, an associate professor of clinical medicine at Weill Cornell Medicine at New York-Presbyterian Hospital.

About 1 in 300 people in the United States experience intermittent periods paroxysmal supraventricular tachycardia, a condition characterised by rapid heartbeat (>100bpm, and more typically 150–200 bpm) in the lower chambers of the heart.

The standard treatment during an episode is to perform vagal manoeuvres, one of which is done by trying to bear down, achieved by breathing out with stomach muscles but not letting air out the nose or mouth. This can make the vagus nerve slow electrical conduction through the atrioventricular (AV) node, which regulates the timing of the electrical pulses to the lower portion of the heart. If the self-administered vagal manoeuvres are not effective (which happens about 20–40% of the time), the person should seek immediate treatment of intravenous medication at an emergency room to return the heart rate to normal. In the United States, about 50,000 emergency room visits a year are for paroxysmal supraventricular tachycardia, Ip said.

In a previous study, people with the disorder treated themselves with either etripamil or a placebo nasal spray for a single episode of rapid heartbeat. Participants applied an electrocardiogram (ECG) patch at the onset of symptoms, did a vagal manoeuvre and self-administered the nasal spray if the rapid heartbeat continued – keeping the ECG patch on for at least five hours. In that study, the first time that etripamil was used without direct supervision, normal heart rhythms were restored within 30 minutes in 54% of patients, compared to 35% with placebo, and the medication was found to be safe and well tolerated. The ECG patch is a wearable heart monitor that has a small device with an adhesive that sticks on the chest skin surface and is wirelessly connected to a cell phone to transmit the ECG data.

All people in that randomised trial were invited to participate in the current open-label study that allowed patients to self-treat with etripamil during multiple episodes of paroxysmal supraventricular tachycardia (PSVT). Of the 169 patients enrolled, 105 self-administered at least one dose of etripamil (70mg) during the median 232-day study period.

The new study found:

  • Etripamil restored heart rate to normal within 30 minutes in 60.2% of the 188 verified PSVT episodes, and within an hour in 75.1% of the episodes.
  • Of the 40 participants who self-treated two episodes, 63.2% responded to the medication within 30 minutes. Nine people (23%) did not convert to a normal heart rate on either episode, and 21 (53%) converted to normal heart rate on both episodes.
  • Safety was assessed regardless of whether the episode was confirmed by ECG. Thirty-four participants (32.4%) reported one or more side effects from the medication, most commonly mild-to-moderate nasal congestion or discomfort, or a runny nose. There were no serious heart-related adverse events.

“There are no great options for patients to self-treat paroxysmal supraventricular tachycardia, and this condition can cause significant distress and anxiety,” Ip said. “Similar to an albuterol inhaler for asthma patients or an epinephrine pen for patients that have severe allergies or anaphylaxis, etripamil nasal spray may be a great option for people who have paroxysmal supraventricular tachycardia.

Source: American Heart Association

Categories : COVID VaccinesTags :

Nasal COVID Vaccines Will Greatly Reduce Transmission

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Source: CDC on Unsplash

Though great progress has been made in developing intramuscular COVID vaccines, as yet nothing provides mucosal immunity in the nose, the first barrier against the virus encounters before it travels down to the lungs.

In terms of both immune cell deployment and immunoglobulin production, the mucosal immune system is by far the largest component of the entire immune system, having evolved to provide protection at the main sites of infectious threat: the mucosae.

In iScience, Navin Varadarajan, Professor of Chemical and Biomolecular Engineering, and colleagues, report the development of an intranasal subunit vaccine that provides durable local immunity against inhaled pathogens.

“Mucosal vaccination can stimulate both systemic and mucosal immunity and has the advantage of being a non-invasive procedure suitable for immunization of large populations,” explained Prof Varadarajan. “However, mucosal vaccination has been hampered by the lack of efficient delivery of the antigen and the need for appropriate adjuvants that can stimulate a robust immune response without toxicity.”

To get around this, Prof Varadarajan worked with Xinli Liu, associate professor of pharmaceutics, and an expert in nanoparticle delivery. Prof Liu’s team packaged the agonist of the stimulator of interferon genes (STING) inside liposomal particles to create an adjuvant called NanoSTING. 

“NanoSTING has a small particle size around 100 nanometres, which exhibits significantly different physical and chemical properties to the conventional adjuvant,” said Prof Liu.

“We used NanoSTING as the adjuvant for intranasal vaccination and single-cell RNA-sequencing to confirm the nasal-associated lymphoid tissue as an inductive site upon vaccination. Our results show that the candidate vaccine formulation is safe, produces rapid immune responses—within seven days—and elicits comprehensive immunity against SARS-CoV-2,” said Prof Varadarajan.

Intramuscular vaccines have a fundamental limitation in that they are not designed to elicit mucosal immunity. As shown in previous work with respiratory pathogens like influenza, sterilising immunity to virus reinfection requires adaptive immune responses in the respiratory system.

The nasal vaccine will also help the equitable global distribution of vaccines, according to the researchers. Many smaller countries have only vaccinated a small percentage of their population, and outbreaks continue. These outbreaks and viral spread are known to facilitate viral evolution, ultimately leading to decreased efficacy of all vaccines.

“Equitable distribution requires vaccines that are stable and that can be shipped easily. As we have shown, each of our components, the protein (lyophilised) and the adjuvant (NanoSTING) are stable for over 11 months and can be stored and shipped without the need for freezing,” said Prof Varadarajan.

Source: University of Houston

Categories : Medical IndustryTags :

Novel Nasal Spray for Migraines Approved by FDA

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Impel NeuroPharma announced that the US Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults.

The innovative system delivers dihydroergotamine mesylate (DHE) through the vascular-rich upper nasal space, bypasses the gut and potential absorption issues, offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after a migraine attack starts. 

During the Phase 3, open-label, pivotal safety study, STOP 301, more than 5,650 migraine attacks were treated over 24 or 52 weeks during the study. The primary objective of the study was to assess the safety and tolerability of TRUDHESA. TRUDHESA was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief. STOP 301 reported TRUDHESA offered consistent efficacy even when taken late into a migraine attack.

“Many of my patients need more from their migraine treatment, and TRUDHESA offers a non-oral, fast-acting, reliable option that overcomes many current medication challenges,” said Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor in the Department of Neurology, and Program Director of the Headache Medicine Fellowship Program, Thomas Jefferson University. “Its upper nasal delivery circumvents the GI tract and common phenomena associated with migraine, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments. And, importantly, it is a self-administered, single dose that can be taken anytime during a migraine attack, so patients don’t need to worry about missing the opportunity to benefit from using TRUDHESA within a certain timeframe. I think patients will be very receptive to this treatment, because it pairs the long-proven benefits of DHE with a patient-friendly delivery system.”

There were no serious adverse events were observed in the study, and most adverse events were mild and transient in nature.

In the STOP 301 study, patient-reported efficacy showed that 38% of patients had pain freedom, 66% had pain relief, and 52% had freedom from their most bothersome migraine symptom at two hours after their first dose of TRUDHESA. In 16% of patients, pain relief started as early as 15 minutes. Of patients who were pain free at two hours, 93 percent were still pain free at 24 hours, and 86 percent were still pain free through two days. The great majority of patients (84%) reported that TRUDHESA was easy to use10 and preferred it over their current therapy.

Source: Impel NeuroPharma