News
New nadf blog: "A day in the life" vignettes
NADF has added a new section to the quarterly newsletter, "A Day in the Life" vignettes. These vignettes will be collected on the NADF website as a blog series. Each entry details a day in the life of someone with adrenal insufficiency and shows them reacting to different stressors. The story is followed by a question section designed to engage the reader in critical thinking about proactive choices for living an adrenal insufficient life of the highest quality. Entries are written by Susan Majka, NADF Treasurer.
Study: "Suicidal thoughts and behaviors among minoritized people with disabilities"
Melissa Shang, a senior at Harvard College majoring in Psychology is conducting a study: “Suicidal Thoughts and Behaviors Among Minoritized People with Disabilities”. This a study explores the impact of stigma and discrimination on mental health and suicide risk among people with disabilities and chronic conditions.
The inclusion criteria for participation are as follows: a) Identifying as a person with a disability or chronic condition. b) Being 18 years of age or older at the start of the study. c) Living in the United States. d) Being fluent in English. e) Having access to the internet.
By completing the survey, participants will be entered into a raffle to win one of forty $25 gift cards. Click here for more detailed information.
Link to the study: bit.ly/smpdstudy
The inclusion criteria for participation are as follows: a) Identifying as a person with a disability or chronic condition. b) Being 18 years of age or older at the start of the study. c) Living in the United States. d) Being fluent in English. e) Having access to the internet.
By completing the survey, participants will be entered into a raffle to win one of forty $25 gift cards. Click here for more detailed information.
Link to the study: bit.ly/smpdstudy
NAEMSP Blog: "Adrenal crisis and addison's disease: what ems needs to know"
The National Association of EMS Physicians (NAEMSP), in collaboration with NADF, has published an article on their blog titled, "Adrenal Crisis and Addison's Disease: What EMS Needs to Know". The article includes information on primary and secondary adrenal insufficiency, EMS treatment of adrenal crisis, and key considerations for EMS. This is part of NADF's ongoing EMS education efforts. NAEMSP.org/adrenal-crisis-and-addisons-disease-what-ems-needs-to-kno/
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EXCITING ANNOUNCEMENT FROM THE ADRENAL INSUFFICIENCY REGISTRY (MYAI) RESEARCH TEAM |
The MyAI Registry participants are invited to enroll into the DNA and Cortisol studies. There is no cost to participate in either study, and you may choose to participate in both! You will be provided with the sampling kits, mailing containers, and shipping labels. Click here for the QR code and more information on how to enroll:
NADF.us/dna-and-cortisol-studies.html
NADF.us/dna-and-cortisol-studies.html
cDC recommends updated covid-19 vaccine
CDC Recommends Updated COVID-19 Vaccine for Fall/Winter Virus Season: CDC.gov/ncird/whats-new/covid-vaccine-recommendations-9-12-2023.html
food outbreak investigations
Food poisoning poses a significant risk, especially for individuals with adrenal insufficiency, as it can lead to adrenal crisis. NADF strongly recommends staying informed about the latest food outbreak reports from the FDA. Ensure you receive timely updates by subscribing to the FDA's Email Updates on Food Recalls & Outbreaks:
FDA.gov/food/recalls-outbreaks-emergencies
For detailed information on current recalls of foods and dietary supplements, please visit the FDA's dedicated webpage: FDA.gov/food/recalls-outbreaks-emergencies/recalls-foods-dietary-supplements
To stay informed about investigations into foodborne illness outbreaks visit:
FDA.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks
Awareness can play a crucial role in ensuring the safety of your health and well-being!
FDA.gov/food/recalls-outbreaks-emergencies
For detailed information on current recalls of foods and dietary supplements, please visit the FDA's dedicated webpage: FDA.gov/food/recalls-outbreaks-emergencies/recalls-foods-dietary-supplements
To stay informed about investigations into foodborne illness outbreaks visit:
FDA.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks
Awareness can play a crucial role in ensuring the safety of your health and well-being!
announcement from neurocrine biosciences
September 12, 2023
Neurocrine Biosciences Announces Positive Top-Line Data from Phase 3 Study of Crinecerfont in Adults for the Treatment of Congenital Adrenal Hyperplasia (CAH). Follow link: neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-positive-top-line-data-phase-3
Neurocrine Biosciences Announces Positive Top-Line Data from Phase 3 Study of Crinecerfont in Adults for the Treatment of Congenital Adrenal Hyperplasia (CAH). Follow link: neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-positive-top-line-data-phase-3
recreating the adrenal gland in a petri dish
Read about this important study that could lead to new therapies for adrenal insufficiencies and a deeper understanding of the genetics of such disorders. penntoday.upenn.edu/news/penn-vet-recreating-adrenal-gland-petri-dish
nadf meeting with fda
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July 12, 2021
We are an adrenal disease community bonded by our shared experiences, and finally, the US Food and Drug Administration (FDA) had a chance to hear about it. Organized by Lori Engler, NADF Executive Director, the session described topics that are most important to the community. The presentation was conducted by several NADF leaders to educate and bring awareness to these topics, clearly explain how they affect our community and to suggest solutions.
Patient Listening Sessions help the FDA understand what is important to patients, caregivers, and advocates when medical products are being developed. The format was a one-hour discussion designed to help those involved in the drug approval process understand the obstacles and unmet needs of patients with adrenal insufficiency.
Here's a summary of topics discussed during NADF’s meeting with the FDA. For each topic, NADF discussed possible solutions, including immediate needs: Modified release hydrocortisone options, Autoinjector for hydrocortisone, and better protection of life-preserving medications to prevent shortages.
According to the FDA, “Patient Listening Sessions are a resource for the medical product Centers to quickly engage with patients for their advocates and are one of many ways the patient community can share their experience with a disease or condition by talking directly with FDA staff.” The FDA hopes to better understand the burdens that diseases and treatments have on our daily lives and to learn what is important for our community.
This was a strong starting point and a very important new direction for NADF. Just a couple of days after the meeting the FDA shortage database was updated…a positive sign that they really were listening.
We are an adrenal disease community bonded by our shared experiences, and finally, the US Food and Drug Administration (FDA) had a chance to hear about it. Organized by Lori Engler, NADF Executive Director, the session described topics that are most important to the community. The presentation was conducted by several NADF leaders to educate and bring awareness to these topics, clearly explain how they affect our community and to suggest solutions.
Patient Listening Sessions help the FDA understand what is important to patients, caregivers, and advocates when medical products are being developed. The format was a one-hour discussion designed to help those involved in the drug approval process understand the obstacles and unmet needs of patients with adrenal insufficiency.
Here's a summary of topics discussed during NADF’s meeting with the FDA. For each topic, NADF discussed possible solutions, including immediate needs: Modified release hydrocortisone options, Autoinjector for hydrocortisone, and better protection of life-preserving medications to prevent shortages.
- Topic I: How can the FDA help create significant drug innovation in the management of adrenal insufficiency? How can we place a higher priority on new adrenal insufficiency treatments given patients’ lower quality of life and higher mortality rates?
Novel modified-release hydrocortisone preparations are available in Europe and have been shown to improve quality of life, improve innate immunity responses, lead to weight reduction, and reduce hemoglobin. NADF leaders also emphasized the need for Solu-Cortef Emergency Administration Technology and explained adrenal crisis is recognizable by its typical symptoms of diarrhea, vomiting and nausea. Unfortunately, the delay between the start of these symptoms and the administration of emergency treatment is the principal cause of death. - Topic II: Drug shortages have been a significant problem especially given the lack of options for treatment of life-preserving medications. Drug shortages can be a matter of life and death.
NADF discussed the issues created by shortages including treatment interruption, transitions to less-effective treatments, and rationing of life-saving treatments.
According to the FDA, “Patient Listening Sessions are a resource for the medical product Centers to quickly engage with patients for their advocates and are one of many ways the patient community can share their experience with a disease or condition by talking directly with FDA staff.” The FDA hopes to better understand the burdens that diseases and treatments have on our daily lives and to learn what is important for our community.
This was a strong starting point and a very important new direction for NADF. Just a couple of days after the meeting the FDA shortage database was updated…a positive sign that they really were listening.
Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) in the United States
November 24, 2020
DEER PARK, Ill., (GLOBE NEWSWIRE): Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the full availability of ALKINDI® SPRINKLE for sale and distribution in the United States.
SEE FULL ANNOUNCEMENT: ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-availability-orphan-drug-alkindir
DEER PARK, Ill., (GLOBE NEWSWIRE): Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the full availability of ALKINDI® SPRINKLE for sale and distribution in the United States.
SEE FULL ANNOUNCEMENT: ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-availability-orphan-drug-alkindir
eton pharmaceuticals announces fda approval of orphan drug alkindi® sprinkle (hYDROCORTISONE) AS REPLACEMENT THERAPY IN PEDIATRIC PATIENTS WITH ADRENOCORTICAL INSUFFICIENCY
September 29, 2020
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children. Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020.
SEE ARTICLE: globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children. Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020.
SEE ARTICLE: globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html
