TheraQuest receives 2nd Orphan Drug status for
neuralgia drug
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BY OUR PHARMA CORRESPONDENT
13th August,2005:TheraQuest Biosciences
announced that the FDA Office of Orphan Products
Development has granted a second Orphan Drug
Designation for TQ-1017, its abuse deterrent
once-daily extended release tramadol for the
management of postherpetic neuralgia.
Postherpetic neuralgia (PHN) is a chronic,
debilitating neuropathic pain syndrome that occurs
as a complication of shingles or herpes zoster
infection. The pain of PHN is unrelenting and is
often described as burning, stabbing or aching.
In addition to persistent pain, patients with PHN
experience episodic pain due to abnormal
sensations from normal daily activities such as
putting on a shirt or contact with a cool gentle
breeze. If untreated, postherpetic neuralgia can
adversely affect a patient’s quality of life.
Patients frequently fail to obtain complete pain
relief with existing treatments or develop
troublesome side effects, the company said in a
news release.
Topical lidocaine patch (Lidoderm), gabapentin (Neurontin)
and pregabalin (Lyrica) are the only approved
treatments for postherpetic neuralgia. Tramadol’s
pain relieving effects are due to multiple
mechanisms of action, including serotonin and
norepinephrine reuptake inhibition and opioid
receptor activation. The current consensus is that
multimodal analgesic therapy may be necessary to
exploit the benefits of drugs with different
mechanisms of action.
The new, long-acting formulations of tramadol in
development are designed to gradually release
their much larger tramadol content over a 24-hour
period. TQ-1017 was engineered from the outset as
a secure-release formulation of once-daily
tramadol. It cannot be easily crushed for
inhalation or to obtain rapid euphoria from high
blood levels when swallowed. It is also difficult
to extract tramadol from the once-daily
formulation using common solvents, including
alcohol, the release noted.
TheraQuest Biosciences is a development-stage pain
management company . Despite their limitations,
current treatments for acute and chronic pain
yield worldwide sales in excess of $25 billion.
The TheraQuest team has contributed to the
development of numerous analgesics approved in the
U.S. over the past 20 years. TheraQuest’s strategy
is to use its expertise to identify, develop and
commercialize product candidates with strong
market potential that have lower development costs
and reduced regulatory risk than new chemical
entities. TheraQuest is headquartered in Blue
Bell, Pennsylvania.
TheraQuest is funded in part by BioAdvance, the
Biotechnology Greenhouse of Southeastern
Pennsylvania and Ben Franklin Technology Partners
of Southeastern Pennsylvania.
BY OUR PHARMA CORRESPONDENT |
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