Five patients in the study reported a serious AE; three in the AOD9604 20 mg group (basal cell carcinoma, moderate lipoma and squamous cell carcinoma), one in the 5 mg group (breast cancer) and one in the 10 mg group (malignant melanoma). According to the investigator, none of the SAEs reported were considered to be possibly, probably or definitely related to study medication (see discussion).
AOD9604 is also known as the ANTI OBESITY DRUG and has been found to target abnormal fat stores (e.g. buttocks, knees, chin, abdomen, and flabby arms). AOD is a Peptide fragment of hGH which is a fat loss and healing properties. Because AOD is a fragment of the C-terminus of hGH, it contains the fat reducing capability of hGH, but does not adversely affect your blood sugar levels or your IGF-1 levels.
Application would result in all current OTC paracetamol/ phenylephrine products being up-scheduled to S3. Applicant’s justification for changing current combination products from exempt or S2 to S3 is on theoretical basis only, and no evidence provided of clinical risk. Pharmacokinetic study found that co-administration of paracetamol with phenylephrine increased plasma phenylephrine levels – applicant says this has potential for cardiac safety risk in susceptible patients.
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