FDA Has Approved A New Medication Treatment For Migraines In Adults

Updated Feb 6, 2025 | 05:09 PM IST

SummaryMany people use the terms ‘migraine’ and ‘headache’ interchangeably. This leads many people to believe that migraines are not as serious as people make them out to be, and that cannot be more wrong, migraines have a major effect on a person’s lifestyle and the new approved medication may prove to be a great relief!
(Credit-Canva)

(Credit-Canva)

Headaches are a common symptom of a stressful lifestyle, your body not feeling well and other issues. While headaches can be dealt with easily, migraines are not so easy to handle. Migraines are a type of headache that feels like severe throbbing and pulsing sensation, almost like you are hearing your own heartbeat in your brain, usually on one side of the brain. Many people believe that migraines are not that big of a deal because you just have to deal with the pain, but that is not all migraine is, some people find it very difficult to do their daily tasks as they experience dizzying spells, nausea and extreme sensitivity to light and sound! These attacks can last hours and make it difficult for people to go about their daily lives as well. While there are medications available for migraine patients, these medications need time to take effect, so you may be in a lot of pain, but there are not many quick reliefs you can have in place other than learning the symptoms of a migraine attack and taking medication before it happens. But a new approval by the FDA may change this!

The U.S. Food and Drug Administration (FDA) has approved Symbravo, a new medicine to treat acute migraine attacks in adults. This means adults can now use Symbravo to get relief from their migraine symptoms. The FDA's decision was based on the results of three big studies, called Phase 3 trials. These trials involved over 21,000 migraine attacks, so the FDA has a lot of information about how well Symbravo works and how safe it is. The FDA only approves medicines that have been shown to be both safe and effective through a thorough testing process.

Importance of New Treatment Option

"Migraine attacks can happen suddenly and really mess up people's lives. It's estimated that over 39 million people in the U.S. alone get migraines," said Herriot Tabuteau, M.D., CEO of Axsome Therapeutics told US News. This shows how common migraines are and how important it is to have good treatments. "Symbravo gives patients and doctors a new option that can quickly stop a migraine attack, keep it away, and let people get back to their normal activities, all with just one dose." Having a medicine that can give fast and long-lasting relief from migraine pain is a big deal for millions of people. This new treatment is a real step forward in how we treat migraines.

Symbravo Trial Results, How Was It Approved

The trials took place in 3 steps, the Momentum trial study focused on people whose migraines had moderate to severe pain. The results showed that a lot more people taking Symbravo felt pain-free two hours after taking the medicine compared to those who took a placebo which is a dummy pill. Even better, many people felt relief for up to 24 and even 48 hours after just one dose. This long-lasting relief is really important for people with migraines because it means they can get back to their normal lives without worrying about the pain coming back. The study also looked at how many people were free from their worst symptom, like sensitivity to light or sound, or nausea. Symbravo worked better than the placebo in this area too.

While the intercept trial looked at people who took Symbravo when their migraine pain was still mild. Even when the pain was just starting, Symbravo was effective. The results were similar to the MOMENTUM trial, with many people getting pain relief and relief from their worst symptoms. Treating migraines early is often better because it can stop the pain from getting really bad.

And lastly the Movement trial which was to see how safe the medication is when people take it regularly. This study followed 706 people who had at least two migraines a month. The most common side effects people experienced were sleepiness and dizziness. While these side effects are important to know about, the study showed that Symbravo is generally safe for people to use on a regular basis.

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Amid Increasing Cases, 7 Out Of 10 GPs In The UK Say Adult ADHD Is Overdiagnosed

Updated Sep 21, 2026 | 08:00 PM IST

SummaryA recent survey of 829 general practitioners stated that attention-deficit/hyperactivity disorder (ADHD) is alarmingly overdiagnosed in adults. Health officials have urged against relying too much on self-assessment.
Amid Increasing Cases, 7 Out Of 10 GPs Say Adult ADHD Is Overdiagnosed

Credit: AI

Seven in 10 general practitioners in the United Kingdom believe adult attention-deficit/hyperactivity disorder (ADHD) is being overdiagnosed, according to a survey of 829 doctors.

The observation has reignited debate over the dramatic increase in adult ADHD referrals and diagnoses.

The survey, conducted by GP publication Pulse, found that 410 GPs described adult ADHD as “very overdiagnosed” while 173 considered it “slightly overdiagnosed”.

Only 50 said it was diagnosed about right, while 148 believed it was underdiagnosed to some degree.

Pulse said that the survey should be viewed as a GP's opinion rather than a proven scientific estimate of overdiagnosis.

The survey also found that GPs estimated an average of 81.3% of patients they referred to adult ADHD services eventually received a positive diagnosis.

But that figure does not mean that 81% of people with suspected ADHD have it. These patients had already been referred for an assessment by a specialist, meaning they had passed through an initial clinical screening process.

Doctors Are Concerned About ADHD Overdiagnosis In Adults

Some GPs responding to the survey raised concerns that assessments may sometimes be too narrow and focus on identifying ADHD without considering other conditions that can cause similar symptoms that could overlap with ADHD. These can include anxiety, depression, trauma and other mental health conditions.

One GP told Pulse that they were concerned about “superficial” assessments and whether patients’ histories of trauma or adverse childhood experiences were being considered accurately.

There are also concerns around the growing use of private assessment providers. Some GPs surveyed said they believed positive diagnosis rates were higher among private providers than NHS services, although these are individual doctors’ observations rather than evidence represented nationally.

At the same time, Dr Katie Bramall, chair of the BMA's GP committee, argued that a high positive diagnosis rate among referred patients is not necessarily evidence of overdiagnosis.

She said lengthy NHS waits may mean that only people who remain convinced that ADHD is affecting them significantly eventually reach assessment.

She also pointed to changing understanding of ADHD, including how it can present in women and adults, as one reason more people are being recognised.

Also read: Botox And Fillers: UK Watchdog Says Clinics Should Check Mental Health Before Injecting

Is ADHD Being Overdiagnosed?

An interim report from the UK government's independent review of ADHD, autism and mental health conditions said recorded ADHD diagnoses in England have increased, particularly among younger adults and women.

The NHS's independent ADHD Taskforce has previously estimated adult ADHD prevalence at around 2-3%, while recorded diagnoses were significantly lower in earlier datasets. The taskforce concluded that under-recognition remained a problem.

The Royal College of Psychiatrists has also agreed that the rise in diagnoses should not be automatically interpreted as overdiagnoses of ADHD.

It has pointed to other factors like better awareness and improved recognition, while also addressing concerns about online self-assessment that may not be always accurate.

The government review therefore says that the current situation is more complex than simply labelling ADHD as either overdiagnosed or underdiagnosed. It highlights the lack of recent, large-scale representative data measuring adult ADHD prevalence in England.

On the other hand, demand for ADHD treatment continues to climb. NHS figures cited by Pulse show prescriptions for ADHD medicines increased by 29% between July 2025 and June 2026 compared with the previous 12 months, with an average of 238,000 patients receiving these medicines each month.

Also read: ADHD: Your Pupils May Explain How The Brain Handles Attention, Says New Indian Study

Signs of ADHD

For people asking themselves if they might have ADHD, one must look to medical sources over social media popularity. The NHS says that signs of ADHD in adults are most often:

  • Difficulty with organization and time management
  • Having trouble with following instructions
  • Having trouble keeping one's focus on tasks and seeing them through
  • Feeling restless or being impatient
  • Risk-taking and being impulsive
  • Trouble in relationships or in social situations

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India Launches Biovigilance Program To Strengthen Organ Transplant Safety

Updated Sep 21, 2026 | 05:00 PM IST

SummaryMoS Anupriya Patel said that around 1,150 Adverse Drug Reaction reporting centers are currently operational across public and private hospitals and medical colleges in the country, along with medical-device vigilance facilities. The government plans to expand these capabilities to the primary healthcare level.
India Launches Biovigilance Program To Strengthen Organ Transplant Safety

Credit: PIB

Medicine safety must become everyone’s responsibility, the Indian government said today while launching the Biovigilance Program to monitor adverse events linked to organ and tissue transplantation.

Under the program, the Indian Pharmacopoeia Commission (IPC) will lead efforts to strengthen the reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplantation, including products administered to donors and recipients.

Together, pharmacovigilance, materiovigilance and biovigilance initiatives will strengthen safety monitoring across medicines, medical devices and transplant procedures.

The program was launched by Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers Anupriya Patel at the 6th National Pharmacovigilance Week organized by the IPC at Dr. Ambedkar International Centre in New Delhi.

New Medicine Safety Initiatives

Patel also launched initiatives to help healthcare professionals make informed, evidence-based decisions when prescribing and using medicines. These include:

  • The 7th Edition of the National Formulary of India (NFI),
  • The Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Device-Related Adverse Events,
  • The ADR-PvPI 2.0 Mobile App for iOS users.

“Rational use of medicines and continuous safety monitoring are integral to public health,” said Patel. She added that “every patient must receive the right medicine, of assured quality, in the right manner and with the highest possible degree of safety”.

“The NFI serves as an important bridge between scientific standards and clinical practice, guiding healthcare professionals in the appropriate and rational use of medicines,” Patel said.

India’s Pharmacovigilance Network

Patel emphasized that medicine safety is a continuous responsibility—from the development and manufacture of a drug or medical device to its prescription, dispensing, use and post-market monitoring.

She also highlighted the country’s progress in pharmacovigilance, noting that “India has built a strong indigenous ecosystem capable of generating, collecting, processing and analyzing medicine-safety data from across the country”.

India has moved from the 123rd position during 2009–2014 to 8th globally in contributions to the WHO patient safety database, Patel said.

The Pharmacovigilance Program of India (PvPI), coordinated by the National Coordination Centre at IPC, systematically collects, assesses and analyzes adverse drug reaction information. The Materiovigilance Program of India (MvPI) monitors adverse events associated with medical devices.

AI And Patient Reporting

Patel said digital initiatives, including NFI Online, IP Online, ADR-PvPI 2.0 Mobile App and the Adverse Drug Reaction Monitoring System (ADRMS), are making medicine-related information and adverse-event reporting more accessible, transparent and responsive.

She called for greater use of emerging technologies, including artificial intelligence and advanced data analytics, to strengthen medicine-safety systems and enable timely generation and use of safety evidence.

The Minister also stressed the need to increase patient participation in adverse-event reporting. She noted that digital platforms, mobile applications and helplines have made reporting easier, and called for addressing the “missing link” of patient reporting.

"Around 1,150 ADR reporting centers are currently operational across public and private hospitals and medical colleges in the country, along with medical-device vigilance facilities. The government plans to expand these capabilities to the primary healthcare level," Patel said.

India’s Patient Safety Push

Referring to the vision of Viksit Bharat 2047, Patel said patient safety must remain a key national priority. She called for India to build on its position as the “pharmacy of the world” and aspire to become a global leader in pharmacovigilance sciences and patient safety.

“Medicine safety must become everyone’s responsibility. Every single reported event can save a life.”

She said collective participation would be critical to building a strong culture of medicine safety and promoting the rational use of medicines.

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LSD-Based Treatment Clears Second Phase 3 Trial: Could It Be The First New GAD Drug In 2 Decades?

Updated Sep 21, 2026 | 07:00 PM IST

SummaryThe second Phase 3 trial of an experimental LSD-based drug for generalized anxiety disorder showed significant promise, setting stage to become the first new drug in 20 years.
LSD-Based Treatment Clears Second Phase 3 Trial: Could It Be The First New GAD Drug In 2 Decades?

Credit: AI

An LSD-based treatment has cleared its second Phase 3 trial for generalized anxiety disorder (GAD), sparking hope to bring the first new drug for the condition in nearly two decades closer to FDA approval.

Definium Therapeutics recently said that its drug DT120, a tablet containing lysergide, the pharmaceutical form of LSD, significantly reduced anxiety symptoms compared to placebo in the Panorama Phase 3 trial that included 245 participants.

The company said participants receiving a single 100-microgram dose had a 9.8-point reduction in their score on the Hamilton Anxiety Rating Scale (HAM-A) after 12 weeks, compared to a 4.7-point reduction among those receiving placebo. The difference with placebo was 5.1 points.

The improvement surfaced quickly as differences from placebo seen as early as Day 2 and sustained through the 12-week assessment.

A Promising Second Phase 3 Trial

Also read: World Patient Safety Day: Why Insulin Innovation in Diabetes Care Demands an Ecosystem Approach

Panorama is the second positive Phase 3 trial for DT120 in GAD. An earlier Phase 3 study, called Voyage, also found a significant improvement in anxiety symptoms, with a placebo-adjusted difference in HAM-A of 5.4 points at 12 weeks.

Phase 3 trials are generally the pivotal studies in any research as they are used to provide evidence of a treatment's efficacy and safety before regulatory review and approval.

Rob Barrow, Chief Executive Officer of Definium Therapeutics, said, “The Panorama results again met our high expectations and confirmed the unprecedented efficacy of DT120 in GAD.”

Barrow added, “With strong positive results across four complementary studies, we have built a compelling body of evidence that increases our confidence in the potential best-in-class profile of DT120.”

The drug also hopes to bridge the long-overdue treatment gap in GAD. Definium says the last new drug approved for GAD was in 2007, meaning DT120 could potentially become the first newly approved GAD treatment in almost 20 years if it ultimately clears regulatory review.

Definium has a pre-New Drug Application meeting with the US Food and Drug Administration planned for the fourth quarter of 2026 and anticipates filing its application in the first half of 2027.

Barrow also said, “Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting. We are deeply grateful to the participants, investigators, site personnel, and our team whose commitment and hard work made this progress possible.”

Also read: After Lindsay Clancy Trial, Massachusetts Pushes Stronger Postpartum Mental Health Screening

LSD-Based Treatment For GAD

DT120 is designed as a single-dose treatment rather than a daily tablet. In the Panorama trial, participants were monitored for at least eight hours after dosing because LSD can temporarily lead to certain cognitive and emotional changes.

Among those receiving 100 micrograms, the average time to meet the study's end-of-session criteria was 6.2 hours, while 94% met those criteria within eight hours.

The treatment works through the serotonin 5-HT2A receptor, although exactly how LSD produces longer-lasting improvements in psychiatric symptoms remains unclear.

The company reported that DT120 was generally well tolerated. It also said that side-effects were mild to moderate, temporary and occurring mainly on the day of dosing.

Among people receiving the 100-microgram dose, common adverse events on dosing day included illusions in 68%, nausea in 37% and headache in 24%. There were no drug-related serious adverse events or signals of increased suicidality in the trial, according to Definium.

It is important to know that these results are reported by the company, and the complete data will need regulatory and scientific scrutiny for the drug’s approval.

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