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Information |
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Generic Name:
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lidocaine + prilocaine spray
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Trade Name: |
Lidocaine/Prilocaine Plethora (EU); Tempe |
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Synonym: |
PSD502 |
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Entry Type: |
New formulation |
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Developmental Status |
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UK: |
Approved (Licensed) |
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EU: |
Approved (Licensed) |
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US: |
Phase III Clinical Trials |
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UK launch Plans: |
Available only to registered users |
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Actual UK launch date: |
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Comments |
Mar 14: A New Drug Application (NDA) is on track for submission with FDA in Q2 14 [9].
11/03/2014 14:34:55 |
Mar 14: Plethora are advertising global licensing & distribution opportunities for Tempe spray [9].
11/03/2014 14:34:19 |
Nov 13: Approved in the EU [8].
11/03/2014 14:29:46 |
Sep 13: EU positive opinion for lidocaine/prilocaine Plethora (150 mg/ml + 50 mg/ml) cutaneous spray for the treatment of primary premature ejaculation in adult men [7].
20/09/2013 15:30:04 |
Mar 13: Product appears on CHMP list of medicines under eva luation, no further updates are available on company website.
08/04/2013 11:42:46 |
Jun 12: Filed in the EU for treatment of premature ejaculation, based on the findings of two pivotal PIII trials in more than 600 pts. Plethora is currently in dicussions with potential co-promoters [6].
05/07/2012 16:41:28 |
Regulatory filing in EU and US expected in 2009 (1)
13/01/2009 13:10:23 |
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Trial or other data |
Jul 09: Company report that the second of two PIII studies with identical protocols met the co-primary endpoints. Results from first study were reported in Nov 08. Data from the two studies involving 540 patients will be combined for submission for regulatory approval in the US and EU. In the second study, intra-vaginal ejaculation latency time (IELT) with PSD502 increased at least six-fold vs baseline (p<0.0001). There was a five-point difference between PSD502 and placebo in the Index of Premature Ejaculation (IPE) domains for ejaculatory control and sexual satisfaction and a 2.5-point difference in the IPE domain for Distress (p<0.0001); a two-point difference for each of these domains is considered clinically significant [5].
29/07/2009 22:24:32 |
Apr 09: PIII results presented at the American Urological Association Annual Meeting (4).
30/04/2009 14:02:10 |
268 of the original 275 patients have enrolled in an optional 9-month non-blind extension study to the European study (3)
01/04/2009 14:14:34 |
Nov 08: Results of double-blind phase of European study reported. Lidocaine/prilocaine increased the Intra-vaginal Ejaculatory Latency Time vs placebo (geometric mean 4 vs 1 min), and reduced the Index of Premature Ejaculation (IPE) Ejaculation Control domain score by 7 points and the IPE Sexual Satisfaction domain score by 6 points vs placebo (co-primary endpoints; all p<0.001) (2).
13/01/2009 13:15:27 |
Two phase 3 studies; a US/Canada 12 study in 265 pts with an optional 5 mo nonblind phase; a European study in 275 pt with an optional 9 mo non blind phase (1)
13/01/2009 13:13:10 |
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Evidence Based eva luations |
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Other |
http://www.plethorasolutions.co.uk/wp-content/uploads/2010/01/TEMPE-Topical-Eutectic-Like-Mixture-for-Premature-Ejaculation-presented-at-CURY-2008.pdf |
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References |
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Available only to registered users |
