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Prescription Cannabidiol (CBD)
EmpowerPharm is developing a prescription cannabidiol (CBD), designed to be consumed orally in a solid dose format. We source our CBD API from a Canadian supplier with a GMP facility approved by Health Canada.
SIGNIFICANT GLOBAL UNMET NEED IN SOCIAL ANXIETY DISORDER
- Social anxiety disorder (SAD) is a mental health condition characterized by intensefear, anxiety, or embarrassment in social situations. Social anxiety treatment is a way of addressing this disorder and helping individuals to manage their symptoms.
- SAD affects 15 million adults or 7.1% of the U.S. population. SAD is equally common among men and women and typically begins around age 13. According to an ADAA survey, 36% of people with social anxiety disorder report experiencing symptoms for 10 or more years before seeking help.
- The Social Anxiety Treatment market was valued at USD $11.8B in 2022 and is projected to reach USD $16B by 2030, at a CAGR of 3.9% during the forecast period.
- The Drug Medication segment was valued at USD $6.6B in 2022 and accounted for 56% of Social Anxiety Treatment Market in 2022. It is forecasted to grow at a CAGR of 3.89% during 2023-2030 and it will be USD $9.0B in 2030.
- Limited Innovation in 20 years
References:
Global Social Anxiety Treatment Market, Forecast to 2030 – Infinity Business Insights
NIMH: Social Anxiety Disorder.
THE POTENTIAL BLOCKBUSTER SOLUTION...
PRESCRIPTION CBD,
Developing the world’s first CBD prescription medication indicated for Social Anxiety Disorder.
Prescription drug to be approved in USA, Canada, and globally, allowing patients to be reimbursed by insurance companies and drug formularies
High quality standardized dosages with enhanced bioavailability and IP protection
Manufactured under GMP Standards at our own
facility with a Drug Establishment Licence
Alternative anxiety treatment, not physically addictive as with benzodiazepines, and with fewer side effects than anti-depressants (SSRI/SNRI)*
References:
* https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604171/
CANNABIDIOL SAFETY INFORMATION
- CBD was well tolerated in clinical trials testing single oral doses of 5 to 6000 mg and multiple oral doses of up to ~3000 mg/day.
- More concerning side effects, such as alanine transaminase (ALT) liver enzyme elevation resulting in high laboratory ALT test values, only occurred in studies where daily dosing of CBD exceeded 1500 mg per day, well above the dosage range of 300 -600 mg explored in EmpowerPharm’ s Phase 2 dose finding clinical study for SAD
- Most frequent adverse events in healthy subjects: somnolence, headache, nausea, diarrhea, and abdominal pain/discomfort
- Most frequent adverse events in patients with seizure disorders (for which CBD solution is approved in the USA, EU and Australia): somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor-quality sleep; pyrexia; vomiting, and infections. Some of these are associated with concomitant use of antiepileptics.
- In patients with anxiety or other psychiatric disorders, adverse events were generally similar to those described in healthy subjects when no concomitant medications were used.
- The use of CBD is not associated with abuse potential or withdrawal symptoms
References:
Detailed white paper on Cannabidiol safety and tolerability