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New Drugs Online Report for capsaicin patch
Information
Generic Name:
capsaicin patch 
Trade Name: Transacin (US), Qutenza (EU) 
Synonym: NGX-4010, Qutenza 
Entry Type: New formulation  
 
Developmental Status
UK: Launched 
EU: Launched 
US: Pre-registration (Filed) 
UK launch Plans: Available only to registered users
Actual UK launch date: 01/07/2010 
Comments
The FDA has accepted for review the Company´s supplemental new drug application for Qutenzaź for the management of neuropathic pain associated with HIV-associated peripheral neuropathy. The FDA has granted Qutenza a priority six month review classification, assigning a Prescription Drug User Fee Act action date of March 7, 2012 [25]. 
16/11/2011 09:51:11
Has been launched in several EU countries including Germany & Austria (Apr 10), & Poland & Czech Republic (Jul 11) for neuropathic pain & postherpetic neuralgia [24]. 
17/10/2011 08:47:55
Sept 11: Supplementary New Drug Application submitted to the US FDA to expand licence for Qutenza 8% patch to include an indication for the management of pain due to HIV-associated peripheral neuropathy (HIV-PN) and HIV-distal sensory polyneuropathy (HIV-DSP). [23]  
09/09/2011 08:58:53
Oct 10: Plan to file in US for HIV-associated neuropathy in 1H 2011. The submission will supported by data from two completed PIII studies. Qutenza has orphan drug status and fast track designation for this indication in the US [22]. 
22/10/2010 13:38:13
Jul 10: Qutenza launched in the UK for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other analgesics. As a condition of licensing, Astellas has produced a training programme for health professionals on use of Qutenza [21]. 
16/08/2010 10:34:32
Apr 10: Qutenza launched in US [20]. 
06/04/2010 09:26:08
Nov 09: Capsaicin 8% patch (Quetenza) approved in US for post-herpetic neuralgia (19)  
18/11/2009 11:40:21
Aug 09: Decision from FDA now expected by 16 Nov 09. Hope to launch in US 1H 2010 [18]/ 
06/08/2009 20:22:42
Jun 09: The FDA has requested data on Qutenza in PHN after 60 minute pre-treatment with an FDA approved local anaesthetic (2.5% lidocaine / 2.5% prilocaine) (studies to date have used a non FDA approved OTC topical anaesthetic). The company hope to submit the data prior to Aug 09, but it may delay the decision date [15]. 
14/06/2009 22:17:34
Jun 09: Granted orphan drug status in US for postherpatic neuralgia pain. Decision on marketing approval expected mid-Aug 09 (14) 
05/06/2009 08:51:25
May 09: Approved in EU for peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain (13). 
26/05/2009 11:57:59
Mar 09: EU positive opinion for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain (12) 
21/03/2009 22:10:43
Dec 08: Company anticipate EU marketing decision 1H09 (11) 
04/02/2009 12:03:43
Oct 08: Filed in US for the management of pain due to postherpetic neuralgia (6) 
27/10/2008 22:26:18
PIII trials in UK(1). Positive results announced for PIII trial (3). Filed in EU Sep 07 (4). Plan to file in US 2H 08 (5). 
 
Trial or other data
Jul 09:Company report preliminary results of a short-term study (Study C123) of Qutenza in patients with postherpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic (2.5% lidocaine / 2.5% prilocaine). The study was requested by the FDA who are expected to make a decision on licensing by August 16, 2009. In the study of 24 patients the mean duration of Qutenza patch application (primary endpoint) was 60.2 minutes, vs a target duration of 60 minutes. No patients removed the Qutenza patch prematurely (.< 90% of the intended full application time) [17]. 
28/07/2009 22:43:46
Jun 09: To be marketed in the EU by Astellas [16]. 
23/06/2009 09:27:08
Data from the phase III trial ACTIVE-1 has shown that capsaicin patch narrowly missed its primary endpoint of reducing post-surgical pain vs. placebo (p=0.07) following bunionectomy surgery at four to 32 hours post-surgery. However, the same measure was highly significant (p=0.004) from four to 48 hours post-surgery. The secondary endpoint of reducing opioid use for capsaicin patch vs. placebo was highly significant (p=0.012) over the four to 32 hour period. Adverse events were similar for both active treatment and placebo groups. (10) 
04/02/2009 12:00:11
PIII study in 402 pt described below published in Dec 08 issue of Lancet Neurology. (9)  
13/01/2009 16:34:53
Nov 08: Results of a 12-week a multicentre trial published in which 402 patients with PHN of ≥6 month duration were treated with one 60-min application of NGX-4010 (8% capsaicin) or a low-concentration capsaicin control patch (0.04% capsaicin). The average baseline numeric pain rating scale (NPRS) score was 3-9. The mean changes in NPRS score from baseline to weeks 2-8 (primary endpoint) were −29.6% vs. −19.9% respectively (difference −9.7% [95%CI −15.47 to −3.95] p=0.001). 42% vs. 32% of patients had a ≥30% reduction in mean NPRS score (odds ratio 1.56 [1.03 to 2.37] p=0.03). Erythema and pain at application site were common but short-lasting (7).  
03/11/2008 18:57:57
Oct 08: US filing supported by two pivotal studies in patients with PHN. Results show a statistically significant reduction in pain from baseline for up to 12 weeks after a single 60-minute application of the dermal patch, administered either as a monotherapy or in combination with other systemic neuropathic pain medications. The most common adverse reactions were redness, pain, and itching at the application site during and shortly after application. The submission includes data on over 2300 patients with neuropathic pain (6). 
27/10/2008 22:29:44
Treatment with high concentration patch (640mcg/c2) appears to reduce painful polyneuropathy associated with HIV infection within 1 hour of application, according to an open label study (1). MC, R, DB PIII study in 307 pts with HIV associated sensory neuopathy showed sig. pain reduction vs control (2). The study met its pre-specified primary endpoint with patients reporting statistically significant pain reduction after a single one-hour application of Transacin, (p=0.001). A significant reduction in pain was noted during the first week following treatment (p=0.04) and was maintained throughout the 12-week study period. At 12 weeks, more than half of all subjects treated with Transacin reported improvement in their condition (3). 
 
Evidence Based Evaluations
Other  http://www.nelm.nhs.uk/en/NeLM-Area/Evidence/Drug-Specific-Reviews/NETAG-issues-recommendation-on-capsaicin-cutaneous-patch-Qutenza-for-neuropathic-pain/ 
SMC  http://www.scottishmedicines.org.uk/files/advice/capsaicin_Qutenza_FINAL_JANUARY_2011_Amended_010211_for_website.pdf 
UKMi  http://www.nelm.nhs.uk/en/NeLM-Area/Evidence/Drug-Specific-Reviews/Capsaicin-cutaneous-patch-Qutenza/ 
NPC  http://www.npci.org.uk/blog/?p=256 
   
References  
Available only to registered users
Category
BNF Category:
Neuropathic pain (04.07.03)
Pharmacology: TRPV1 receptor agonist  
Epidemiology: It is estimated that about 8% of the UK population suffer from neuropathic pain. HIV-associated polyneuropathy affects 29% to 62% of patients with HIV and AIDS.  
Indication: Neuropathic pain 
Additional Details: incl postherpetic, HIV-associated & diabetic neuropathy 
 
Method(s) of Administration
Transdermal 
 
Company Information
Name: Astellas 
US Name: Astellas 
 
NICE Information
In timetable: No  
When:  /  
   
   
PBR Likely in tariff.
   
Service
Implications
Available only to registered users
   
Prescribing
Outlook:
Available only to registered users

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