History
Indalpine: the first worldwide marketeed SSRI and Designated Blockbuster:
While Citalopram (Lundbeck) and Zimelidine (Astra Pharmaceuticals) were developed in the early 70s, it was Pharmuka's indalpine that was first to reach market of all existing SSRIs, and first designated as 'Blockbuster" antidepressant. Dr. Shopsin was recruited as consultant to Pharmuka throughout a timely and orderly R & D process that resulted in the marketing of Indalpine in France and then worldwide, in 1982. The enormous therapeutic success, public excitement and media attention in France relating to Upstène (Indalpine)spread worldwide where patient demand and widepread physician prescribing of this new SSRI antidepressant drug led to another indalpine first: its designation as "Blockbuster" breaking all records for the sale of any antidepressant up to that point in time. With FDA approval of Pharmuka's IND submission to conduct clinical studies with indalpine and Viqueline, Dr. Shopsin carried out and published the first clinical trials with these drugs in depressed outpatients in the U.S. Astra's SSRI Zimelidine was marketed within a year (1983), but the next crop of SSRI's didn't become commercially available until the 1986 marketing of Fluvoxamine in Belgium by Duphar, followed by approval in the United States later that year. Lily's Fluoxetine (Prozac) burst on the scene in the US, in 1987, an event occurrence five years after the advent worldwide marketing of Pharmuka's indalpine.
Indalpine withdrawn and Fluoxetine (Prozac) marketed in 1987
Meanwhile, Zimelidine had been withdrawn soon after its marketing in 1983 due to the emergence of Guillain–Barré syndrome, a serious neurological disease. In a smoldering climate of lingering concerns among some Common Market countries and activist groups about the potential of SSRIs to induce adverse effects, the ill timed occurrence of Indalpine associated hematological effects during the dislocating aftermath of Pharmuka's take over by the pharmaceutical giant Rhône Poulenc under industry nationalization by the socialist Mitterrand government, generated the "The Perfect Storm" sealing Indalpine's fate. In or about 1987, Rhône Poulenc abruptly blindsighted the regulatory authorities, the medical community and patients alike, by pulling Indalpine off the market to the astonishment and protestations of all concerned. David Healy the renowned British psychiatrist characterized the hapless fate of Indalpine as being "born at the wrong time" during a period when "Indalpine and Psychiatry was Under Siege" by different interest groups in some of the Common Market countries. In line with Indalpine's fate, R & D was halted relating to the 2 other 4-alkyl-piperidine derivatives developed by Pharmuka, Viqueline (a 5-HT reuptake inhibitor & 5-HT releaser)and Pipequeline (a 5-HT post-receptor agonist), both in different stages of development at the time.
Recently, revision of this molecular motif yielded SERT inhibitors with nanomolar and subnanomolar IC50 values.
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