Prof. Gary Wittert, Adelaide-based Principal Investigator on the study, said: “As the world’s first drug with a metabolic mechanism of action AOD9604 could occupy a unique position among the options available to doctors for the management of obesity. It is pleasing that the invention and its development from the laboratory bench has been an all–Australian effort.”
This peptide is a modified fragment of hGH which contains the portion of the molecule that is believed to be responsible for hGH’s anti-obesity effects. The peptide has been shown to increase fat burning without the increase in blood sugar and growth rate that has been seen with hGH itself. AOD 9604 has been deemed safe for chronic use by the FDA, receiving Human GRAS status in 2014. In addition to its utility as an anti-obesity peptide, AOD 9604 has been shown to have very favorable cartilage repair and regenerative properties, especially when paired with peptide BPC 157.
To amend Schedule 2 entry to exempt paracetamol when compounded with caffeine, in a powder or granule product containing 1000mg or less of paracetamol and in tablets or capsules containing 500mg or less of paracetamol when paracetamol is the only therapeutic active constituent and when supplied in primary packs of not more than 20 tablets/caplets or 10 sachets of powders/granules.
There are several limitations of our study. Given the nature of our physiologic protocols, which required two large volume saline infusions in obese patients before and after surgery, our sample size was modest. Nonetheless, we were able to elicit significant relationships of all four natriuretic peptides (ANP, Nt‐proANP, BNP, and Nt‐proBNP) across a variety of salt conditions before and after surgical weight loss. Our study population consisted of primarily females. We do not believe from prior epidemiologic studies looking at resting natriuretic peptide levels in obese individuals12 that having more men in our cohort would have modified our findings. Prior epidemiologic studies do not suggest that gender modifies the association between obesity and natriuretic peptide concentrations. We did not examine short‐term changes in the natriuretic peptide system, as a physiologic assessment immediately after surgery would have been impractical and potentially confounded by post‐operative shifts in volume or nutrition. We also focused on surgical weight loss because weight loss with non‐surgical treatments is less consistent. Thus, we cannot exclude any surgery‐specific effects. Because the saline infusion was indexed to BSA, less saline was given at the post‐weight loss visit. This could have created a “conservative” bias, eg, toward observing a smaller natriuretic peptide response after surgery. Indexing was performed to ensure that the amount of saline relative to plasma volume was relatively constant. Lastly, we did not perform a complete assessment of the renin‐angiotensin‐aldosterone system and the sympathetic nervous system, all of which could also be primarily affected resulting in the observed responses of the natriuretic peptide system after weight loss and/or saline loading.
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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