Pfizer’s new at-home pill to treat Covid could be available by end of the year

InnoHEALTH magazine digital team — Tue, 22 Jun 2021 05:20:14 +0000

Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who have contracted the virus. Given the way that the virus is mutating and with its impact globally, it looks like that it will be critical to have access to the therapeutic options both now and beyond the pandemic. Hence, Pfizer has initiated phase 1 study of its novel oral antiviral therapeutic agent against Sars-cov-2. On the brighter side, if this proves to be as effective as it claims, it would be a boon to the healthcare system as it would curtail the shortage of the only existing oral drug (Remdesivir) in the market and will act as a potential oral therapy that could be prescribed at the first sign of infection, without requiring the patients to be hospitalized.

Pfizer CEO Albert Bourla has said that an oral drug for treating coronavirus could be ready next year adding the company is working on two antivirals, an oral and an injectable. “We are actually on two, one is injectable and the other one an oral (antiviral). Particularly the attention is on the oral for the world and of us because provides several advantages and one of them is that you don’t need to go to the hospital to get the treatment of which is the case with all the injectables so far but you can get it home,” Bourla told CNBC in an interview on Tuesday, as cited by The Hill.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that by the end of the year,” Bourla added.

The only antiviral currently approved for use against the coronavirus is Remdesivir, which is manufactured by Gilead Sciences. The US Food and Drug Administration (FDA) gave the drug full approval in October after it was granted emergency use authorization in May last year. He also said the medication could be “way more effective against the multiple variants” of the virus than current options adding that the mechanism of action, of the antiviral, is not expected to be subject to mutations, “particularly because it’s not acting on the spike, as we all know, all the mutations that we are hearing right now are seeing this in the proteins of the spike.”

“This one doesn’t work there so that allows us to believe that will be way more effective against the multiple variants. So, all good news. We are now progressing the studies and we will have more news around summer,” the CEO added. The Hill further reported that thus far, more than 121 million doses of the vaccine have been administered across the United States.

SOURCE: www.hindustantimes.com

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Digital tracking system: Pill to determine medication ingestion

InnoHEALTH Magazine — Wed, 07 Mar 2018 11:14:41 +0000

The U.S. Food and Drug Administration has recently approved a pill with sensor that digitally tracks if patients have ingested their medication

AbilifyMyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

It is important to note that AbilifyMyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. AbilifyMyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.

Schizophrenia is a chronic, severe and disabling brain disorder. About 1 percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age.

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Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

AbilifyMyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. AbilifyMyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify-MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. AbilifyMyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

In the clinical trials for Abilify, the most common side effects reported by adults were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.

Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

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Drug Administration Archives - InnoHEALTH magazine

Pfizer’s new at-home pill to treat Covid could be available by end of the year

Digital tracking system: Pill to determine medication ingestion

The U.S. Food and Drug Administration has recently approved a pill with sensor that digitally tracks if patients have ingested their medication