Headache

Migraine sufferers in England may soon be able to access preventative drug – here’s how atogepant works

Retrieved on: 
Tuesday, April 23, 2024

Atogepant (brand name: Aquipta) was recently recommended by the National Institute for Health and Care Excellence (Nice) to prevent episodic and chronic migraine attacks.

Key Points: 
  • Atogepant (brand name: Aquipta) was recently recommended by the National Institute for Health and Care Excellence (Nice) to prevent episodic and chronic migraine attacks.
  • The drug would be recommended to people who have at least four migraine days a month or where at least three previous preventative treatments have failed.
  • Migraine is a complex neurological condition that affects about 10 million people in the UK.
  • It’s characterised by recurrent, severe headaches that can be made worse by physical activity and are often debilitating.
  • However, it’s only suited to patients who suffer from episodic migraines – whereas atogepant can be used by people who have both chronic and episodic migraines.

Consistently effective


Three clinical trials have shown atogepant to be safe and effective for people with episodic or chronic migraines.

  • The Advance trial evaluated how safe and effective different doses of atogepant were compared with a placebo in preventing episodic migraine.
  • The 60mg once-daily tablet was found to be well tolerated and effective, leading to nearly seven fewer migraine days per month.
  • A third trial, the 302-LTS trial, followed participants who suffered from episodic migraine for over a year, finding that atogepant was consistently effective for reducing migraine attacks.
  • Atogenpant was consistently shown to be safe across all studies, including the one that lasted for a year.


Anna Andreou receives funding from the Medical Research Foundation and Brain Research UK. She also received research funding from eNeura, AbbVie and Pfizer. She is affiliated with the International Headache Society, being elected as a Trustee of the Board. She is Chair of the Headache special interest group of the British Pain Society.

Getting a good night’s rest is vital for neurodiverse children – pediatric sleep experts explain why

Retrieved on: 
Friday, April 19, 2024

If you’re a parent with kids at home, it often leaves you and your children on edge.

Key Points: 
  • If you’re a parent with kids at home, it often leaves you and your children on edge.
  • Children with neurodiverse conditions, such as autism and attention-deficit/hyperactivity disorder, or ADHD, are even more susceptible to the effects of poor sleep, given their emotional reactivity and impulsivity..
  • Struggles with sleep have been linked to increased aggression, irritability, inattention and hyperactivity in children with autism spectrum disorder.

The science behind sleep difficulties

  • There are multiple reasons why neurodiverse children don’t sleep well, including medical conditions, biological causes and behavioral and environmental factors.
  • Medical conditions, such as obstructive sleep apnea or epilepsy, can affect a child’s sleep.
  • Medications that are used to treat medical conditions, such as antidepressants for mood disorders or stimulants for ADHD, can further disrupt sleep.

Treating sleep problems


All of these factors can be addressed and treated. A thorough evaluation by the child’s health care provider may reveal a medical cause, or medication, that is interfering with sleep. Behavioral approaches can make a big difference in improving sleep. These might include:
Changes to daytime habits, including getting lots of morning light and physical activity.
Shifts in evening habits, such as removing all screens (TV, computers, phones, etc.) and establishing calming bedtime routines.
Modifications to how a parent interacts with their child for those families who would like a child to fall asleep and stay asleep independently.

  • It’s important to note that not all families want their children to sleep on their own.
  • Because there are so many factors that can cause disrupted sleep, addressing sleep problems cannot be a one-size-fits-all approach and should be done in partnership with parents.
  • Our team has developed a family-centered approach to address sleep problems in neurodiverse children.

The ups and downs of melatonin

  • While behavioral approaches are recommended as a first-line treatment, melatonin can be helpful in jump-starting a behavioral routine.
  • Overdoses can result from children eating a bunch of gummies, or parents not understanding how much melatonin is safe to give.
  • To help parents sift through all the resources and articles on melatonin on the internet and social media, one of us created a video and wrote several blogs on melatonin safety.
  • These include topics like whether children can become dependent on melatonin supplements over time, whether taking melatonin will delay puberty, whether children might experience side effects from taking melatonin and more.

Promoting healthier sleep


Here are some general tips for helping your child sleep better, regardless of whether they are neurodiverse:
Choose a consistent bedtime and wake time. This consistency will help children’s own natural melatonin kick in.
Make sure bedtime isn’t too early. For example, an 8 p.m. bedtime is too early for most 10-year-olds. Neurodiverse children may struggle to sleep and will become more anxious, which makes going to sleep even harder.
Help your child get natural sunlight in the morning. Morning sunlight sets our brain’s internal clock so that we can fall asleep more easily at bedtime.
Ensure your child is getting physical activity during the day.
Minimize naps longer than one hour, or after 4 p.m. for school-age children. Naps can interfere with going to sleep at night.
Avoid caffeine, including many types of soda, tea and chocolate.
Turn off all screens and smartphones at least 30 minutes before bedtime.
In the evening leading up to bedtime, turn down all lights in the house. Consider using red night lights, if possible. Set any devices to night mode in the evening to limit exposure to blue light.
Create wind-down time in place of screens. Have your child identify an activity they enjoy that is calming and soothing, such as reading a book, coloring or listening to music. If a bath is stimulating, move it to earlier in the evening, such as after dinner.
Help your child learn to fall asleep without needing you or their devices to be there with them. That way, they will settle down on their own at bedtime. And when they wake up throughout the night, since we all wake up in the night, they will be able to go right back to sleep without becoming fully awake.
For more tips, see Autism Speaks for free downloads of brochures and visual aids.

  • She also receives funding from the American Academy of Sleep Medicine.
  • She has received funding from the American Academy of Sleep Medicine and Autism Speaks for research on sleep in children with ASD.

Understanding AI outputs: study shows pro-western cultural bias in the way AI decisions are explained

Retrieved on: 
Thursday, April 18, 2024

If you were affected, you might want an explanation of why an AI system produced the decision it did.

Key Points: 
  • If you were affected, you might want an explanation of why an AI system produced the decision it did.
  • Yet AI systems are often so computationally complex that not even their designers fully know how the decisions were produced.
  • Explainable AI systems help AI engineers to monitor and correct their models’ processing.
  • We wanted to see to what extent researchers indicated awareness of cultural variations that were potentially relevant for designing satisfactory explainable AI.

Cultural differences in explanations

  • The other is externalist, citing factors like social norms, rules, or other factors that are outside the person.
  • However, such explanations are not obviously preferred over externalist explanations in “collectivist” societies, such as those commonly found across Africa or south Asia, where people often view themselves as interdependent.
  • If people from different cultures prefer different kinds of explanations, this matters for designing inclusive systems of explainable AI.
  • Our research, however, suggests that XAI developers are not sensitive to potential cultural differences in explanation preferences.

Overlooking cultural differences

  • Moreover, when we checked the cultural background of the people tested in the studies, we found 48.1% of the studies did not report on cultural background at all.
  • This suggests that researchers did not consider cultural background to be a factor that could influence the generalisability of results.
  • Of those that did report on cultural background, 81.3% only sampled western, industrialised, educated, rich and democratic populations.
  • Yet, out of the studies that reported on cultural background, 70.1% extended their conclusions beyond the study population – to users, people, humans in general – and most studies did not contain evidence of reflection on cultural similarity.

Why the results matter

  • To address this cultural bias in XAI, developers and psychologists should collaborate to test for relevant cultural differences.
  • As AI is being used worldwide to make important decisions, systems must provide explanations that people from different cultures find acceptable.
  • As it stands, large populations who could benefit from the potential of explainable AI risk being overlooked in XAI research.


The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, 21/08/2020 Withdrawn

Retrieved on: 
Thursday, April 18, 2024

Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, 21/08/2020 Withdrawn

Key Points: 


Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, 21/08/2020 Withdrawn

Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine

Retrieved on: 
Tuesday, March 26, 2024

"We are excited to announce our fourth infectious disease vaccine program with positive Phase 3 data, further validating our robust mRNA platform," said Stephane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • "We are excited to announce our fourth infectious disease vaccine program with positive Phase 3 data, further validating our robust mRNA platform," said Stephane Bancel, Chief Executive Officer of Moderna.
  • "mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much needed vaccine to market."
  • In the NextCOVE (NCT05815498) Phase 3 pivotal trial, mRNA-1283 was shown to elicit a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222.
  • A detailed analysis of the Phase 3 clinical trial data for mRNA-1283 will be shared at the Company's Vaccines Day event on March 27 and presented at upcoming scientific conferences.

Introducing Protomentum – The Ideal Accelerated Product Development Partner

Retrieved on: 
Monday, April 8, 2024

SYDNEY, NOVA SCOTIA, April 08, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Protocase, the leader in B2B custom electronic enclosures and precision sheet metal fabrication for a wide range of industries including aerospace via its ProtoSpace division, is thrilled to announce the launch of its new division: Protomentum. This innovative venture is poised to revolutionize product development by providing an all-encompassing solution for founders, venture capitalists, innovators and established companies seeking rapid time-to-market via a single best-in-class partner with decades of proven processes and experience. Great products only happen after multiple iterations, and our ultra-fast manufacturing lets you iterate and refine quickly, achieving a much higher standard than possible with fewer, slower development cycles. Additionally, Protomentum's flexible manufacturing enables you to make multiple versions for market quickly for high-value, low-volume products.

Key Points: 
  • In today’s fast-paced business landscape where efficiency is do or die, time is of the essence, especially for early-stage companies and first-time product runs.
  • However, the traditional product development process often hinders progress due to fragmented workflows.
  • Current standalone options for product design are not ideal; the choice is either hiring an external design agency, or having mechanical designers/engineers on staff, both of which are cost prohibitive.
  • That’s why we created Protomentum, the one-stop solution for rapid product development and a true game changer in manufacturing solutions.

AEON Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Friday, March 29, 2024

IRVINE, Calif., March 29, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • We are now well-positioned to plan for the initiation of our pivotal Phase 3 program,” commented Marc Forth, AEON’s President and Chief Executive Officer.
  • “Recently, we announced plans to conduct an interim analysis of our ongoing Phase 2 study of ABP-450 as a preventive treatment for chronic migraine, which completed enrollment in December 2023.
  • On track to announce topline results from the Phase 2 study of ABP-450 as a preventive treatment for chronic migraine in the third quarter of 2024.
  • Episodic Migraine Program Next Steps – The Company is continuing to plan for the initiation of its proposed pivotal Phase 3 program for ABP-450.

atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression

Retrieved on: 
Wednesday, March 27, 2024

The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants.

Key Points: 
  • The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants.
  • Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study.
  • Initial analysis showed that a single dose of BPL-003 induced a rapid antidepressant response2 in 55% of patients on the day after dosing.
  • The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year.

Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

Retrieved on: 
Tuesday, March 26, 2024

CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH). This proof-of-concept study was not powered to demonstrate statistical significance.   The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.

Key Points: 
  • CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial ( NCT05668754 ) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH).
  • The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.
  • The results from the completed Phase 2 trial provide key information for the design of a potentially pivotal Phase 3 trial of KP1077 in patients with IH.
  • The Company plans to request an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to seek guidance on the Phase 3 clinical trial design.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, March 26, 2024

“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.