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FAQ about Synolis VA

1. Do you have data about pain relief persistent effect (3 months and beyond) of Synolis VA?

Yes, we have an open label study of 1147 OA patients. Using the Likert scale to assess pain, the mean change in pain due to OA was 56.5% from baseline to 6 months1.

2. I’ve seen other HA- polyol products, but they use Mannitol. Why did you choose Sorbitol for Synolis VA?

A priority in the development of Synolis VA was to ensure Hyaluronic Acid (NaHA) is protected against premature degradation due to oxidation by free radicals.
The antioxidant properties in sorbitol come from the number of hydroxyl groups on the molecule, as well as its spatial conformation. Sorbitol is known to be a good anti-oxidant in the polyol family and is a stronger antioxidant than Glycerol and Mannitol.
Besides, Sorbitol is an endogenous molecule (not Mannitol) and synthesized in various parts of the body (eyes, liver, kidneys and nervous system cells) which means the body recognizes it as its own and can easily process and eliminate it.

3. Isn’t it Sorbitol that is providing all the protection? Why should I not just use Sorbitol alone?

Sorbitol is a small size molecule and very soluble, if injected alone it will most likely be eliminated by the body very rapidly.
If NaHA is injected alone it is exposed to free radicals that degrade it.
The matrix of low energy bonds formed between the Sorbitol and NaHA help the NaHA to stay longer in the joint (it is protected against cleaving) and deliver full performance.
Sorbitol is in Synolis VA to protect the NaHA during the shelf life and after injection from premature degradation caused by free radicals.

4. Does sorbitol affect diabetic patients?

Diabetic patients are safe using Synolis VA. Sorbitol is metabolized by the liver, largely as fructose, a carbohydrate that is highly tolerated by people with diabetes. 2ml of Synolis VA contains 40 mg of Sorbitol, which is a negligible quantity for influencing blood sugar level.
No side effects have been reported in relation with this topic.

5. Is molecular weight important to deliver better patient benefits?

This topic is quite controversial and as a result, medical societies do not give any recommendation in this respect. Various in-vitro tests have been carried out the results of which were inconclusive as they showed that both high or low molecular weight HA can have a benefit on the chondrocytes or extra cellular matrix.
To date we are not aware of any in-vivo tests that have been carried out to assess this though a meta-analysis of a hyaluronic acids vs Hylan G-F20, showed no advantage with higher molecular weight HA, and indicated more safety concerns with Hylan2
The HA concentration is thought to be more important than its molecular weight for the viscosity of the synovial fluid3

6. How do you explain the quick pain relief that is specific to Synolis VA and not seen in other viscosupplements?

The mechanism that supports the quick pain relief of Synolis VA is not yet fully understood. It is likely to be a combination of the following:

• immediate reestablishment of physiological pH-osmolarity due to the buffered formulation of Synolis VA
• good lubrication due to rheology of Synolis VA (close to the physico-chemical characteristics of healthy human synovial fluid) that reduces the creation of inflammatory molecules, in turn influencing the sub-chondral bone
• Barrier effect of NaHA covering the nociceptors which produces a masking effect reducing pain

7. How can I use Synolis VA and corticoid at the same time? What data do you have to support this?

Aptissen does not have data supporting the mix of steroids and Synolis VA. Nonetheless it is important to remind you that if the intention of mixing NaHa and steroids/anaesthetics is to reduce the pain quicker than a regular NaHA would do, that is not necessary with Synolis VA, due to the quick onset of pain relief provided after one injection.
Mixing steroids or anesthetic and NaHA is quite a widespread practice, although there is no data to ensure chemical compatibility of all the molecules. It is known that anesthetic and steroids can be deleterious for the cartilage or the sub-chondral bone. It has also been shown that mixing NaHA with steroids or contrast agent decreases the visco- elasticity ty and can possibly destroy the NaHA chains.

8. Pain management and injection ?

Intra-articular injections of SYNOLIS VA may cause temporary pain, oedema and/or effusion and the patient is advised to avoid intense physical activity for at least 48 after injection. These reactions usually clear up in a few days. If these symptoms persist for over a week, or if any other side effects occur, the patient must inform his or her physician.
Some ice placed on the joint for 1⁄2 hour after the injection can help to reduce pain associated to the injection if any is experienced.

9. How can you confirm the early efficacy claims? What support do you have?

Over 10 independent observational studies on Synolis VA, enrolling a total of 1’500 patients, showed the same effect on the pain relief, in that 50% of the pain relief is gained in a maximum one week after the first injection1,5- 13.
Patients reported the pain relief is as quick as within the 2 days following the 1st injection, which is comparable to a steroid effect in Doctors mind.

10. What is your pharmacovigilance service? Do you have a client service centre for advice?

A materiovigilance system is in place, which conforms to European regulations concerning Medical Devices manufacturers.
Any adverse event must be communicated to our mail address: info@aptissen.com. A response is provided in less than 24H.


References
1. Heislel. Drug Res, 2013;63(9):445-449
2. Reichenbach S et al. Arthritis Rheum, 2007;57:1410-8
3. Aviad AD, Houpt JB. J Rheumatol 1994;21:297-301
4. Conrozier, T.ECCEO, 2011.
5. Bausani Osteoarthritis and Cartilage, 2016 (24);Supplement 1:S530