LEO Pharma aerosol foam for psoriasis submitted to FDA

[Fred]

A new Aerosol foam treatment for psoriasis has been submitted to the US Food and Drug Administration (FDA) by LEO Pharma, the aerosol foam formulation is a fixed combination calcipotriene/betamethasone dipropionate 0,005%/0,064%.

Quote:

---

LEO Pharma announced it has submitted a New Drug Application to the US Food and Drug Administration (FDA)for calcipotriene/betamethasone dipropionate aerosol foam 0,005%/0,064% for the treatment of psoriasis vulgaris.

The novel aerosol foam formulation of the fixed combination calcipotriene/betamethasone dipropionate has been developed with the aim of improving treatment for patients with psoriasis vulgaris – the most common clinical form of psoriasis.

The regulatory submission in the US is based on studies of patients with psoriasis vulgaris. These include the Phase 3a PSO-FAST study which evaluated efficacy, safety, itch relief and itch-related sleep loss across a four week period, and the Phase 2 MUSE safety study.

Kim Kjøller, Senior Vice President, Global Development, commented:

“Psoriasis is a chronic, debilitating disease. Patients with inadequately managed psoriasis can experience substantial burden of illness, with similar reductions in quality of life to those experienced by patients with diabetes or cancer.

With the regulatory submission announced today, we are taking a step further in our mission towards reducing this burden by making calcipotriene/betamethasone dipropionate aerosol foam available for people living with psoriasis.”

Regulatory filings in Europe and other countries are planned during the course of 2015 and 2016.

With this latest submission LEO Pharma reinforces a strong commitment to dermatology.

Source: leo-pharma.com

[jiml]

I wonder  how it will work putting it on, it will be interesting to see how it's applied
I would have hoped for a spray applicator as is used fo sun tan lotions etc.... But at least they are trying new things ..... And it does show a commitment to dermatological problems, albeit the same goods but wrapped differently

[Fred]

I wonder  how it will work putting it on, it will be interesting to see how it's applied
I would have hoped for a spray applicator as is used fo sun tan lotions etc.... But at least they are trying new things ..... And it does show a commitment to dermatological problems, albeit the same goods but wrapped differently

Yes I wasn't sure on the thinking behind it as I would have thought it's better to get a cream rubbed into the skin as opposed to it just laying on top, if they say you still need to rub it in then I don't see the point myself.

Also wouldn't a foam be more wasteful than a cream?