SUPLASYN is a specialized viscosupplement medical device indicated for the symptomatic treatment of osteoarthritis and joint pain. It is a trademarked brand primarily managed by Mylan Pharma Group Ltd. (now part of Viatris).

Manufacturer and Ownership

Primary Owner:
The SUPLASYN trademark is held by Mylan Pharma Group Limited.

Production and Distribution:
The product is manufactured in Ireland. Distribution is handled through various regional partners, including Viatris Pharmaceuticals, Inc. and Bioniche Life Sciences (via Devries & Co. Ltd.) in specific markets like Israel.

Regulatory Status:
In the European Union, SUPLASYN is classified and CE-marked as a Medical Device (CE0473), not a drug. It is approved for clinical use in Canada but is generally not listed as FDA-approved in the United States.

Product Overview and Mechanism

Core Component:
SUPLASYN is composed of a sterile sodium hyaluronate solution (10 mg/ml).

Mechanism of Action:
It acts as a viscoelastic supplement to temporarily restore the lubricating and shock-absorbing properties of synovial fluid. By improving the rheological properties of the synovial space, it reduces joint friction and stiffness.

Application Areas:
It is administered intra-articularly (directly into the joint space) for affected areas including the knee, hip, toe, shoulder, and hand.

Product Variants and Formulations

SUPLASYN is available in several pre-filled syringe formats tailored for different joint sizes and treatment durations:

Suplasyn 20mg/2ml:
Typically administered in a regimen of one injection per week for 3 to 6 weeks.

Suplasyn 1-Shot (60mg/6ml):
A higher concentration formulation designed for single-dose administration to provide relief.

Suplasyn m.d.:
Specifically indicated for use in small synovial joints.

Clinical Indications and Benefits

Osteoarthritis Relief:
Indicated for symptomatic treatment to alleviate pain and improve physical function.

Post-Arthrocentesis:
Used as a replacement for synovial fluid following arthrocentesis (joint fluid removal) to help normalize the joint environment.

Efficacy:
Clinical studies suggest it is more effective than placebo for knee osteoarthritis, with efficacy comparable to non-steroidal anti-inflammatory drugs (NSAIDs) but without gastrointestinal side effects. Benefits can last up to 6 months for mild to moderate cases.

Usage and Safety Precautions

Administration:
Must be performed by a qualified healthcare professional using aseptic techniques.

Patient Aftercare:
It is recommended that patients rest the treated joint and avoid strenuous activity for 24 to 48 hours following injection.

Contraindications:
It should not be used in patients with known hypersensitivity to the product, or those with active joint inflammation or irritation. It is also not recommended for children, pregnant women, or lactating women due to a lack of clinical evidence in these groups.

Common Side Effects:
Short-lasting local reactions may occur, such as pain, redness, swelling, or a feeling of heat at the injection site.