The Office of Tissue and Advanced Therapies (OTAT) has provided more guidance in regards to approval of Ampion™, which is expected to be helpful in the lessening of pain that results from severe Osteoarthritis of the knee (OAK).
“Ampion™ is doing pretty well as stated by the Osteoarthritis Research Society International (OARSI) which outlines an about 50% response rate which was arrived at after administering injections to a significant number of patients. Additionally, it was discovered that the drug posed no serious drug-related side effects.
Ampio Pharmaceuticals Inc (NYSEMKT:AMPE) intends to pioneer a study on a number of patients with severe OAK. The proposed 6-1 randomization seeks to do away with bias and to uphold blinding as well. A very careful and objective evaluation is set to be put up which will see to it that the Ampion™ treated patients are considered in terms of coming up with lasting solutions for them.
There is a proposed design of this 12-week study which is in a quest to try out patient response to Ampion™ and it is through some careful evaluation that the research will establish the actual response rate which will be important in determining a lot of things which at the end of the day will target improving the condition of the patients.
Ampio Pharmaceuticals has filed a request to seek out the approval of this serious medical condition which according to it is a medical condition which with an “unmet need”. Incase it gets approved; the Biotech Stocks Alerts will indicate that to the general public.
Osteoarthritis (OA) happens to be a continuous form of progressive complication that affects joints. At times it degrades ligaments, joint lining, intra-articular cartilage and bone. Research indicates that osteoarthritis has much to do with conditions such as diabetes, aging, and obesity.
The natural wear and tear goes along towards destroying the cartilage. Osteoarthritis usually results from inflammation of bony structures of the joints as well as that of the soft tissues. A lot is being done towards reaching for a better tomorrow and if any significant progress comes up, it will be aired out in the Biotech Stock News.