Journavx Approved, GLP-1s Broaden Benefits
FDA approves novel pain medication & GLP drugs display broader benefits than previously thought
Journavx: A New Era in Acute Pain Management
The Food and Drug Administration (FDA) recently approved Journavx (suzetrigine) 50 mg oral tablets for the treatment of moderate to severe acute pain in adults . This non-opioid analgesic, manufactured by Vertex Pharmaceuticals, is the first drug in a new class of pain management medications known as sodium channel blockers, and the first new class of pain medicine approved in over 20 years
1. Overview of Journavx:
Journavx (suzetrigine) is a new, non-opioid medication for moderate to severe acute pain in adults.
Manufactured by Vertex Pharmaceuticals, it's the first in a new class of sodium channel blockers.
The wholesale price is $15.50 per 50mg pill, more expensive than generic opioids, but considered cost-effective.
2. Key Differences from Opioids:
Mechanism: Opioids affect the brain's opioid receptors, while Journavx blocks pain signals in the peripheral nervous system.
Addiction Risk: Opioids have a high addiction risk, while Journavx shows a low risk.
Side Effects: Opioids can cause sedation, constipation, and respiratory depression, while Journavx's side effects include itching, muscle spasms, and rash. It should not be taken with strong CYP3A inhibitors or grapefruit products. It may also affect fertility and hormonal contraceptives.
3. Market Implications:
Journavx offers a non-opioid alternative for acute pain, potentially decreasing opioid prescriptions.
Its approval may reduce opioid abuse and misuse, and could shift the paradigm of care in pain management.
Other non-opioid pain medications are also in development.
Journavx is being explored for other conditions, such as neuropathic pain.
4. Reactions to the Announcement:
Vertex Pharmaceuticals stock is up 16.5% YTD, however, it’s too soon to speak to the penetration this new drug could unlock in the pain market.
Positive reactions from healthcare professionals, patient groups, and the public.
Healthcare professionals see it as a foundational treatment for acute pain without addiction risks.
GLP-1 Drugs Exhibit Broader Benefits
An observational study using VA data of nearly 2 million individuals, including 215,970 new GLP-1 drug users with type 2 diabetes, and 1,203,097 patients with type 2 diabetes on other medications, was conducted over a median of 3.68 years.
1. What was the study:
The study aimed to investigate the risks and benefits of GLP-1 receptor agonists.
Participants were mainly older, white, military veterans.
2. Key Outcomes:
GLP-1 agents were associated with reduced risks for 42 diverse outcomes, increased risks for 19 outcomes, and no association with 114 outcomes compared to usual care.
Significant benefits included:
Reduced risk of neurocognitive disorders, including dementia and Alzheimer's disease.
Decreased risk in nervous system-related issues, such as substance use disorders, suicidal thoughts, and seizures.
Lower risk of infections, respiratory conditions, and blood clotting issues.
Reduced risk of cardiovascular issues, such as heart attack and stroke.
Reduced risk of kidney issues, anemia, and other conditions.
Notable risks included:
Increased gastrointestinal problems.
Higher risk of hypotension, sleep disturbances, and headaches.
A 2.46-fold higher risk for drug-induced acute pancreatitis.
3. Implications for GLP-1 Drugs:
GLP-1 agonists appear to have broad effects beyond diabetes management, possibly due to their impact on obesity, inflammation, and endothelial function.
The study suggests that these drugs may have wide ranging benefits at the cost of more manageable gastrointestinal side effects.
This bodes well for the Novo Nordisk and Eli Lilly’s duopoly on the weight loss market as they can potentially be prescribed off-label in the near term and get more indications approved in longer term. Both showed strong Q4 earnings on the back of their GLP treatments, with Eli Lilly having 45% YoY and Novo Nordisk with 29% for the same time period last year.