AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-injector for Subcutaneous Use

AMAG Pharmaceuticals has announced that it has submitted supplemental new drug application (sNDA) to the US FDA for the Makena® subcutaneous auto-injector, a drug-device combination product.client-logo-amag-color

The current Makena intramuscular (IM) injection is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women. Patients receiving Makena® should inform the healthcare provider whether they are allergic to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena.

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New Enhanced Neuroprotective Properties of Undecylenic Acid

Here is an interesting article on the enhanced neuroprotective effects of undecylenic acid.

Undecylenic acid, a synthetic unsaturated fatty acid obtained from castor oil is a well-known potent antifungal agent. In 2012, scientists from Korea found that undecylenic acid has the ability to inhibit µ-Calpain activity, a factor responsible for neurological disorders like Alzheimer’s disease.  This showed the neuroprotective effects of Undecylenic acidundecylenic acid.

Now scientists from Poland have done an experiment to improve the efficiency of neuroprotective effects of undecylenic acid by targeting it using polyelectrolyte coated nanocapsules. Core shell nanocapsules were prepared using nanoemulsification and the layer by layer technique. The average size of nanocapsules was around 80nm and the concentration was 2.5×1010 particles/ml. The nanocapsules were coated with either polycation or polyanion layers.

Biocompatibility of the synthesized nanocarriers was evaluated in SH-SY5Y human neuroblastoma cell line using cell viability/toxicity assays.

Results showed that nanocapsules coated with PLL and PGA were non-toxic to the human neuroblastoma cell line, thereby showing its potential to be used as a carrier of undecylenic acid.  Further research showed that nanoencapsulated form of undecylenic acid was biocompatible and more effective against staurosporine-induced damage in lower concentrations than those of the same drug added directly to the culture medium.

This shows that undecylenic acid could be more effective in nanoencapsulated form against neurological disorders.

Wish to know more about undecylenic acid – see here

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