Drug Evaluation Archives - InnoHEALTH magazine

Guildelines Released for Evaluation of Nanopharmaceuticals

InnoHEALTH Magazine — Fri, 10 Jan 2020 10:48:21 +0000

On 24th October 2019 in New Delhi, the Minister for Science & Technology, Earth Sciences and Health & Family Welfare released the guidelines for evaluation of nanopharmaceuticals, which are emerging as more potent tools for treating various diseases.
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The document, which covers all the aspects of evaluation from the definition and categorization of nanopharmaceuticals to pharmacovigilance of the new set of therapeutics, has been prepared as a joint project by the Department of Biotechnology in the Ministry of Science and Technology, and Indian Council of Medical Research and Central Drugs Standard Control Organisation in the Ministry of Health and Family Welfare.
Nano-pharmaceuticals, which are derived by the application of nanotechnology in medical therapeutics, are expected to bring about a revolution in the treatment strategies as they would enable target-specific delivery of drugs and therapeutic molecules and thus offer higher efficacy and lower toxicity in many disease conditions. They are expected to be of great use particularly in cancer treatment.
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Every year, several new nanopharmaceuticals are being developed and marketed across the world. India too has a sizable pool of nanoscientists generating a large number of scientific publications in this domain. However, regulatory approval is the most important factor for translating laboratory research into bedside medicine. The new set of guidelines is designed to facilitate this process.
Noting that the document has been prepared by domain experts in consultation with representatives of the industry, Dr. Harsh Vardhan, Hon’ble Minister of Health and Family Welfare expressed confidence that it will give a big boost to innovators and drug manufacturers to optimize their research and come out with medicines that would be safer and more affordable.
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Hon’ble Minister Dr. Vardhan also announced a three-day international conference that was organized by the Department of Biotechnology and Confederation of Indian Industry in New Delhi from November 21-23, 2019 in collaboration with the Association of Biotech-Led Enterprises (ABLE) and Biotechnology Industry Research Assistance Council (BIRAC), which is a public sector undertaking under DBT to showcase India’s prowess in the area of biotechnology and help build new partnerships and investment opportunities.
Titled Global Bio-India 2019, the meet deliberated on opportunities and challenges in the areas of bio-agriculture, bio-industry, bio-energy, bio-services, and biopharma sectors. It had several components including policy dialogues, investors’ round tables, a meeting of regulators across the world and an exhibition.

Credits: India Science Wire

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Nasal Spray for Treating Depression

InnoHEALTH Magazine — Wed, 30 Oct 2019 05:54:07 +0000

The US Food and Drug Administration (FDA) approved ketamine on 6th March 2019 —a ketamine like nasal spray, which is to be taken in conjunction with one of the commonly used oral antidepressants —to help in treating a form of depression called treatment resistant depression (TRD). TRD is a condition that typically affects people suffering from major depressive disorders (MDD). The key feature of TRD is the inability to respond adequately to at least two antidepressant treatments.

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The drug is administered via the nasal route, where it is absorbed by the nasal lining into the bloodstream. Part of the promise that ketamine holds, lies in the role it plays in swiftly alleviating depressive symptoms. Esketamine is reported to show statistically significant effects as quickly as a matter of days, as against the traditional antidepressant treatments that can take several weeks before showing any results.

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“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, MD, Acting Director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a press release announcing its approval. Unsurprisingly, the FDA’s approval has been hailed as a landmark milestoneby its advocates.

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Given the potential risk of abuse and the risk of serious adverse outcomes, like sedation and dissociation (disconnect in a person’s thoughts, memories and a sense of identity) among others, associated with administering of the drug, the drug will only be available through a restricted distributed system. In addition, the drug will only be administered in a clinical setting where patients are required to stay back and be monitored for a few hours.

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Ketamine as a drug has been around for many years and has been used off-label to treat depression. Many psychiatrists in India provide ketamine infusion therapy, which is essentially ketamine administered intravenously, as it is felt to be beneficial during emergencies and especially in patients diagnosed with suicidal ideation.

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An average of about 4.4% of the world and 5.9% of the United States’ population, suffer from varying degrees of depression and the incidence in India is not vastly different at 4.5%. Insuch a scenario, where the incidence rates are similar, treatment options for depression available around the world are required to be made available here in India as well. It is, therefore, incumbent on all the stakeholders to deliberate the efficacy and the potential harm of the drug expeditiously, and if found suitable for the Indian population, fast track its availability.

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Despite Ketamine’s success in giving the patient a new impetus to recovery, it is important to sustain the gain. All aspects of a patient’s disease, from the physical to the psychological and from the social to the environmental need to be addressed. Ketamine is really a shift in thinking about and acting on depression, which really represents a leap in terms of new ideas for tackling the disease.

About the author

Preetam Satish is the co-founder of a health-tech company Virtual Clinic. He is also a stakeholder in Maarga Hospital, a psychiatry hospital based in Bangalore. Mr. Satish is passionate about mental health and has written an article about the new and emerging treatments available for depression. He has also written about how Ketamine is important to fast track the availability of some of these known and well-entrenched therapies to address the needs of mental health in India.

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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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