THALIDOMIDE (TALDO)

Medicinal product containing thalidomide for treatment of hereditary haemorrhagic telangiectasia (HHT) obtained the orphan designation by EMA (On 27 February 2017). A nasal powder formulation with suitable technological properties was designed to enable thalidomide administration in the nose and to provide to HHT patients treated by oral thalidomide, a complementary anti-epistaxis therapy. Furthermore, this approach could let sustaining the effect obtained with the oral treatment after its interruption.

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CISPLATIN (HYALCIS)

The product under development obtained the orphan designation EMA (On 29 August 2016): cisplatin is a thin and flexible polymeric film, sufficiently resistant to be applied intrapleural or in other districts, adhering to the mesothelial or epithelial surfaces. Preclinical studies on rats showed that hyaluronate films loaded with cisplatin were significantly more effective in reducing tumour recurrence and assuring higher and prolonged plasmatic drug concentrations than cisplatin solution, without increasing systemic toxicity. Moreover, the protocol assistance, i.e. the list of experiments required to get the marketing authorisation, has already been discussed and approved by EMA.

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AMIKACIN (AMIKA PS)

Amikacin powder for inhalation (125 mg, twice daily) obtained the orphan designation by FDA (5th of January 2015) and EMA (16th of December 2014), EU/3/14/1397 for the management of chronic lung infections caused by Pseudomonas aeruginosa in adults and children aged six years and over, who have cystic fibrosis. The orphan designation guarantees a period of marketing exclusivity following the marketing approval (10 years in EU; 7 years in US) and fee reduction during development. Moreover, the protocol assistance, i.e. the list of experiments required to get the marketing authorisation, has already been discussed and approved by EMA.

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TOBRAMYCIN (TOBRA PS)

A tobramycin dry powder inhaler (112 mg, twice daily) has been studied as well in order to offer an alternative medicine to the actual product on the market. In particular, PlumeStars developed a tobramycin powder providing a clinical superiority/significant benefit versus the commercial medicine, hence improving the compliance of the therapy.

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