Lidocaine/Prilocaine Plethora（150毫克/毫升+50毫克/毫升）-利多卡因/丙胺卡因皮肤喷雾器
用于原发性早泄的治疗
新药+利多卡因丙胺卡因喷雾报告信息
通用名称：利多卡因+丙胺卡因喷雾
商品名称：利多卡因/丙胺卡因多如牛毛（欧盟）;坦佩
同义词：PSD502
条目类型：全新配方
用于治疗：原发性早泄
发展现状
英国：已批准（许可）
欧盟：批准（许可）
Lidocaine/Prilocaine Plethora 利多卡因/丙胺卡因皮肤喷雾器
Lidocaine/Prilocaine Plethora
| Name | Lidocaine/Prilocaine Plethora |
|---|---|
| Agency product number | EMEA/H/C/002693 |
| Active substance |
lidocaine / prilocaine |
| International non-proprietary name (INN) or common name |
lidocaine / prilocaine |
| Therapeutic area | Sexual Dysfunction, Physiological |
| Anatomical therapeutic chemical (ATC) code | N01BB20 |
Publication details for Lidocaine/Prilocaine Plethora
| Marketing-authorisation holder |
Plethora Solutions Limited |
|---|---|
| Revision | 0 |
| Date of issue of marketing authorisation valid throughout the European Union | 15/11/2013 |
Plethora Solutions Limited
11 Hampden House
Monument Business Park
Chalgrove OX44 7RW
United Kingdom
New Drugs Online Report for lidocaine + prilocaine spray
Information
Generic Name: lidocaine + prilocaine spray
Trade Name: Lidocaine/Prilocaine Plethora (EU); Tempe
Synonym: PSD502
Entry Type: New formulation
Developmental Status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
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
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
Evidence Based eva luations
Other
References
Available only to registered users
Category
BNF Category: Drugs for erectile dysfunction (07.04.05)
Pharmacology: Sodium channel antagonist
Epidemiology: Premature ejaculation (PE) is the most common male sexual dysfunction, with preva lence rates of 20-30%. Limited data suggest that the preva lence of lifelong PE, defined as intravaginal ejaculatory latency time <1-2 min, is about 2 to 5%.
Indication: Premature ejaculation
Method(s) of Administration
Topical
Company Information
Name: Plethora
US Name: Sciele
NICE Information
In timetable: No
When: /
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Content (concentration) Pack size
EU/1/13/881/001
Lidocaine/Prilocaine Plethora
150 mg/ml / 50 mg/ml
Cutaneous spray, solution
Cutaneous use
sprayer (alu)
6.5 ml
1 spray