2015年11月4日，Paratek新型氨甲基四环素类抗生素Omadacycline进入FDA快速通道，每日一次口服或静脉注射治疗急性细菌性皮肤和皮肤结构感染（ABSSSI）、社区获得性细菌性肺炎（CABP）和复杂性尿路感染（cUTI），该药目前正开展III期临床研究。此前FDA已授予该药QIDP资格。
New Drugs Online Report for omadacycline
Information
Generic Name: omadacycline
Trade Name:
Synonym: PTK 0796
Entry Type: New molecular entity
Development and Regulatory status
UK: Phase II Clinical Trials
EU: Phase II Clinical Trials
US: Phase II Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Mar 15: PIII trials are anticipated to start in 2015 [11].
31/03/2015 16:46:13
Apr 14: PII for ABSSSI [10].
28/04/2014 17:20:08
Jan 13: Paratek terminated its US-based PIII study of omadacycline in patients with complicated skin and skin structure infections (cSSSIs) in Nov 12, but has completed the clinical studies required to support initiation of PIII trials in the ABSSSI and CABP indications [8].
28/04/2014 17:17:53
Jan 13: The US FDA had granted Qualified Infectious Disease Product (QIDP) designation for both oral and intravenous formulations of omadacycline for treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The QIDP designation, which was provided under the Generating Antibiotic Incentives Now (GAIN) Act (enacted in July 2012), will confer access to incentives such as priority review, eligibility for fast-track status and five-year extension of exclusivity on FDA approval [7].
29/05/2013 13:36:13
In July 2011, Novartis terminated its collaboration with Paratek on omadacycline, returning all rights to Paratek. Novartis´ reason for termination was that the timing for omadacycline´s regulatory approval had become uncertain [6].
26/04/2012 14:49:31
Filing now planned 2013 [4].
13/06/2011 13:38:51
Filings planned for 2012 [2].
22/03/2010 16:47:06
PIII studies started in US Mar 09 and globally in Jul 09 [1].
10/10/2009 16:48:10
Trial or other data
Apr 14: No clinical trials registered for omadacycline in the US clincial trials registry [9].
28/04/2014 17:18:56
Mar 12: Paratek has reached agreement with the FDA on Special Protocol Assessments (SPA) for its PIII programme to support approval for treatment of serious (acute) bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The trial designs agreed upon through both SPAs are double-blind RCTs comparing omadacycline to standard of care therapies. The SPAs are the first to accommodate the FDA´s new directives on early response endpoints [5].
31/03/2012 19:06:35
Oct 09: There are two registered PIII studies of similar design, one US (NCT00865280; PTK 0796-CSSI-0804) and the other global, (NCT00876850; PTK 0796-CSSI-0805), both comparing oral and IV PTK 0796 vs linezolid to treat cSSSIs. The primary outcome is clinical success at 4 weeks follow up. Each study is enrolling around 790 patients and are expected to be completed by mid-2010. PIII studies in additional indications such as CABP are planned [1].
13/06/2011 13:40:53
Oct 09: Paratek entered into a collaborative development with Novartis. The two companies will share responsibility and costs for worldwide development and Novartis will have the exclusive right to commercialise PTK 0796 [1].
10/10/2009 17:03:30
A PII study met its primary safety and tolerability endpoint, demonstrating no relevant differences between PTK 0796 and linezolid in incidence or pattern of adverse events. In the eva luable population of patients (n=188), the clinical success rates were 98.0% and 93.2% for PTK 0796 and linezolid respectively [1].
10/10/2009 17:03:21
PTK 0796 has a spectrum broad enough for single-agent treatment of life threatening infections such as complicated skin and skin structure infections (cSSSI) and moderate to severe community acquired bacterial pneumonia with activity against resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), multi-drug resistant Streptococcus pneumoniae (MDRSP) and vancomycin-resistant enterococci (VRE). It is given by a 30 minute IV infusion or orally, both once daily [1].
10/10/2009 17:03:11
References
Available only to registered users
Category
BNF Category: Tetracyclines (05.01.03)
Pharmacology: Broad-spectrum antibiotic a first-in-class aminomethylcycline
Epidemiology: The incidence of hospital-onset and community-onset MRSA bloodstream infections in England is 7.8 and 3.5 cases per 100,000 population, respectively (Clin Infect Dis. 2010;51:925-8).
Indication: Skin and skin structure infections
Additional Details: acute bacterial
Method(s) of Administration
Intravenous
Oral
Company Information
Name: Paratek
US Name: Paratek
Further Information
Anticipated commissioning route (England) -
High cost drug list? Awaiting Update
Implications Available only to registered users |
